Lung Cancer Clinical Trials in India: Access, Eligibility and Cost

This page is information, not medical advice. It cannot tell you whether a trial suits you, and it is not a referral. Lung cancer trial eligibility turns on histology, stage, driver mutation, prior treatment lines, organ function and performance status, none of which an article can know. Use it to arrive at a consultation with specific trial identifiers and sharper questions.

Lung cancer is the one solid tumour where the question "is there a trial for me" usually has to be answered twice: once for your driver mutation, and once for what you have already been treated with. A tumour with an EGFR mutation, an ALK or ROS1 fusion, a MET exon 14 skipping alteration or a KRAS G12C mutation opens a different set of protocols from a tumour with none of those, and progression on a targeted drug opens a different set again.

Molecular results therefore decide which protocols can even assess you, and they take time to come back. Ask your treating team which tests are indicated and whether a trial would perform them during screening, rather than assuming you must buy a panel before making any enquiry.

The large American biomarker master protocols are not an option from here. Lung-MAP lists the United States and Canada, and its S1900K substudy is open to US institutions only. What is reachable in India is a mix of globally sponsored phase III studies that have Indian sites, and investigator-initiated studies at the large academic centres. Coordinate enquiries promptly with your treating team, without delaying treatment you need.

Key points

• Ask your treating team early which molecular tests are indicated for your histology and stage, and whether a trial's screening would supply them. You can make trial enquiries while results are pending.
• Search CTRI first. It is India's statutory registry, hosted by ICMR's National Institute for Research in Digital Health. Prospective registration has been required for regulator-permitted trials since 2009, and since April 2018 the registry has refused new retrospective submissions outright, so nearly every legitimate India-based trial appears there.
• Lung-MAP runs in the United States and Canada, and its S1900K substudy is listed for US institutions only. Neither is an access route from India.
• TROPION-Lung-14 (NCT06350097), an AstraZeneca phase III of osimertinib with or without datopotamab deruxtecan, is running at AIIMS Delhi. It is restricted to EGFR exon 19 deletion or L858R, with further eligibility criteria, so the broad label "EGFR-mutant" is not enough to tell whether it applies to you. Confirm current recruitment status at source before travelling.
• The investigational drug is usually sponsor-funded, while sequencing, travel, accommodation and non-protocol supportive care are generally yours. How much that changes your total depends on the protocol, so ask for an itemised written estimate. Reimbursement of travel and incidental costs is permitted with ethics committee approval, so request the study's written policy.

Which biomarker opens which door

Alteration	Roughly how common in NSCLC	Why it matters for trial access
EGFR mutation	Substantially more common in Asian than Western populations	Largest set of targeted protocols; also the group where adding immunotherapy has weak evidence
ALK fusion	Uncommon	Several approved inhibitors, so trials tend to target resistance after progression
ROS1 fusion	Uncommon	Similar pattern to ALK; resistance-stage protocols
MET exon 14 skipping	Uncommon, commoner in older patients	Targeted agents exist; many of the trials are US network studies
KRAS G12C	More common in smokers	A newer target, with protocols still opening
No driver found	Common	Routes are chemo-immunotherapy combinations and perioperative studies rather than targeted ones

Two things to note about that table. The frequencies vary by population and by how the testing was done, so treat them as orientation rather than numbers to quote. And a driver mutation is not automatically good news for a trial search: it often means an approved targeted drug should come first, with trials entering the picture at resistance.

Where lung cancer trials actually run in India

Centre	Location	Sector	What it is for
ACTREC, Tata Memorial Centre	Kharghar, Navi Mumbai	Public academic	Large published Phase I to IV portfolio
AIIMS Delhi (IRCH)	Delhi	Public academic	Running TROPION-Lung-14 (NCT06350097) in EGFR-mutant NSCLC
Rajiv Gandhi Cancer Institute	Delhi	Non-profit tertiary	Standing multidisciplinary tumour board, written second opinions
Apollo Proton Cancer Centre	Chennai	Private tertiary	On-site critical care; proton therapy available
CTRI	Online	ICMR registry	The statutory record you can search yourself, free

ACTREC, Tata Memorial Centre. Its medical oncology department serves over 300 outpatients daily and publishes a portfolio spanning Phase I, I/II, II, III and IV, globally sponsored and investigator-initiated. Contact details are uneven across that list: several haematology studies name an individual contact, while the solid tumour entries, including its lung study, generally do not. So identify the protocol first, then ask the department how to reach that study's investigator rather than assuming a published contact exists. This route costs time rather than money: referral, waiting and screening investigations.

AIIMS Delhi, Institute Rotary Cancer Hospital. IRCH runs a large academic trial portfolio across lung, breast, gastrointestinal and urological cancers, with the low-cost public structure that usually means investigational drugs at no charge. It is associated with TROPION-Lung-14, the AstraZeneca phase III testing osimertinib with or without datopotamab deruxtecan as first-line treatment in EGFR exon 19 deletion or L858R advanced NSCLC. The study is listed as enrolling, with roughly 582 participants planned across two arms. In May 2026 the department advertised a head nurse post naming that protocol, which indicates involvement but is not confirmation that the site is open to patients. Site recruitment status moves independently of a study's overall status, so check NCT06350097 and CTRI, and ask the department directly, before making the trip.

Rajiv Gandhi Cancer Institute and Research Centre. Runs complex cases through a standing tumour board across medical, surgical and radiation oncology with pathology and radiology, and has a documented written second-opinion process. Useful when you want a formal, dated consensus on file before committing to an unusual regimen.

Apollo Proton Cancer Centre. India's first JCI-accredited cancer hospital, with organ-based management teams and on-site critical care. Managing severe immune-related toxicity quickly depends on trained staff and emergency facilities being available, which is why infrastructure is worth asking about. On radiation, a Penn Medicine analysis presented at ASTRO in 2020 reported roughly half the average cardiac dose with proton therapy compared with standard photon radiotherapy for lung cancer. A lower dose to the heart is not the same as a better outcome for you, proton therapy is not a trial, and whether it suits your tumour is a question for a radiation oncologist. Accreditation likewise does not establish outcomes or trial availability.

CTRI. Searchable by phase, state, district and keyword without any referral, and cross-linked to the WHO International Clinical Trials Registry Platform so a listing can be checked against a second source. Registration is a disclosure requirement rather than an endorsement: CTRI does not authenticate submitted documents, so a registration number tells you a trial exists on the record, not that it is safe or suitable for you.

A second opinion on the plan

For an unusual regimen, or when a driver mutation has been found and you are unsure the plan reflects it, a second opinion is reasonable. It is often most useful from outside the team that wrote the current plan, though a different hospital does not by itself mean a reviewer has no competing interest.

Dr Bharat Patodiya is a medical oncologist in Hyderabad holding MBBS, MD and DNB Medical Oncology qualifications and, according to his own practice site, a CAS certificate in lung and gastrointestinal cancer from the University of Zurich. He practises at Pi Cancer Care in Gachibowli, Hyderabad, whose own materials describe a daycare facility and diagnostic services. We have not been able to confirm on-site surgical or radiation oncology there, so ask which services are delivered on site and which are referred out.

We have not found registered trials listed at this practice, so if a trial place is what you need, expect enrolment to happen at a centre running the study. Check CTRI yourself for any site you are considering, including this one. Published directory listings also disagree about years of practice and current affiliations, so verify registration with the relevant State Medical Council or the National Medical Commission and confirm the rest with the practice.

Be sceptical of any service, anywhere, that offers to secure you a trial place. Nobody can. Screening against protocol criteria is done by the trial site, and a screening failure is a normal outcome.

How to search, in order

1. Get the genomic report, or confirm one is being done. Everything downstream depends on it.
2. Search CTRI for lung cancer studies with recruiting status, and note the CTRI reference numbers.
3. Search ClinicalTrials.gov with India as the location filter, note NCT numbers, then open each study's locations list. A study's overall status and an individual site's status can differ, so confirm the specific Indian site before planning travel.
4. Check the trial pages of the centres above. Some protocols appear only on a hospital's own list.
5. For each candidate, write down the identifier, the site, the named contact, and the one or two eligibility criteria you are unsure about.
6. Re-check recruitment status a day or two before your appointment.

Where you are in the illness changes the search

The same diagnosis produces several different trial searches, and people often run the wrong one.

Newly diagnosed with advanced disease, driver mutation found. In this setting an approved targeted drug is commonly the first step rather than a trial, since a trial would often randomise against it. Early-stage disease is different again, where surgery or radiotherapy may lead. Which applies depends on stage, the specific alteration and your overall condition, and sequences differ between alterations. The trials worth asking about are ones that add something to the standard targeted drug, which is exactly what TROPION-Lung-14 does for EGFR. Ask whether a combination study is open before starting, because starting treatment can affect eligibility.

Newly diagnosed with advanced disease, no driver found. Chemotherapy with a checkpoint inhibitor is a common approach, and some patients with high PD-L1 expression are treated with immunotherapy alone. Relevant trials add an agent to that backbone, or test a perioperative sequence where disease is resectable. Ask for the PD-L1 score as a number rather than a yes or no.

Progression on a targeted drug. This setting has the widest range of trials, and it is where a fresh biopsy is most likely to be worthwhile, because the resistance mechanism decides which protocols apply. Progression is not a single state: slow progression in one site is managed differently from widespread progression, and some patients stay on the original drug with local treatment to the progressing site.

Progression after chemo-immunotherapy. Fewer options and more uncertainty, which is also where early-phase studies become a more reasonable thing to consider, as long as the realistic odds are discussed honestly.

Knowing which of these you are in makes the registry search tractable, and it is the first thing a trial coordinator will ask.

Re-biopsy at progression, and why it is worth the trouble

Lung tumours change under treatment, and a genomic report from diagnosis can be out of date by the time a drug stops working.

When an EGFR-targeted drug fails, the reason varies: a new mutation in the same gene, activation of a different pathway such as MET amplification, or the tumour changing histological type altogether, including transformation to small cell. Those lead to completely different next steps, and you cannot tell which has happened without new testing.

A tissue re-biopsy gives the most information, including histology, which a blood test cannot show. A liquid biopsy, meaning circulating tumour DNA from a blood draw, is quicker and less invasive, and is often done first. It has two limitations. A negative result does not reliably exclude an alteration, because not every tumour sheds enough DNA into blood. And it cannot show histology, so a change in tumour type, including transformation to small cell, can only be confirmed on tissue. A negative or uninformative liquid biopsy in someone progressing is a reason to discuss a tissue biopsy, not a reason to stop looking.

Ask when a re-biopsy is being considered rather than waiting to be offered one. It is a procedure with its own risks, and whether it is justified depends on whether the result would actually change the plan. That is a fair question to put to your oncologist directly.

If it is small cell lung cancer

Most of this page describes non-small cell disease, which is the majority. Small cell behaves differently enough that the trial search differs too.

There is no equivalent set of driver mutations to test for, so the biomarker-first approach above largely does not apply. The standard for extensive-stage disease is chemotherapy with a checkpoint inhibitor, and trials generally test additions to that or new agents after progression. Small cell also tends to respond quickly and then relapse quickly, which compresses the time available to arrange anything.

Start the conversation about trials at diagnosis rather than waiting for progression, and ask your oncologist to flag early if a protocol might become relevant, since the window is narrower than in NSCLC.

What participation actually involves

Phase	What it tests	What it means for you
I	Dose and safety, often after standard options are exhausted	Intensive visits and monitoring; benefit is uncertain and varies by study
I/II	Dose finding plus an early look at activity	Small numbers, close follow-up, uncertain outcome
II	Whether activity exists in a defined group	Often single-arm, so everyone receives the investigational agent
III	A new approach against current standard care	Usually randomised; tests comparative efficacy and safety, and can return a negative result
IV	An approved drug in wider use	Closest to ordinary treatment, with added data collection

Beyond the phase, the things that shape daily life are the visit schedule and the scan cadence. Protocol imaging usually runs on fixed intervals regardless of how you feel, visit windows are narrow, and missing them can affect your participation. For anyone travelling from another city, that schedule is more often the deciding factor than the medicine is.

Ask for the visit calendar in writing before consenting, and map it against the travel involved. It is the single most useful document for working out whether participation is realistic.

What decides eligibility in lung cancer

The criteria that most often settle it:

• Histology. Non-small cell versus small cell, and within NSCLC, squamous versus non-squamous. Many protocols admit only one.
• Driver alteration. EGFR, ALK, ROS1, MET, KRAS and others, with the specific variant often mattering, not just the gene.
• Prior treatment lines. How many, and which classes. Protocols are usually written for a precise position in the sequence.
• Brain metastases. Common in lung cancer and handled very differently between protocols. Some exclude them, some require them to be treated and stable, some are designed around them. Ask specifically.
• Performance status. Usually ECOG, where a higher score means greater impairment and protocols set an upper limit, commonly 0 to 1 or 0 to 2.
• Organ function. Blood counts, kidney, liver and cardiac thresholds, plus lung function, which carries more weight here than in other cancers.
• Washout period. A minimum interval since the last treatment. Raise it early, because treatment timing and a possible trial need coordinating between your treating oncologist and the trial investigator. Preserving eligibility is never a reason on its own to delay treatment you need.

What it costs, and the part people miss

The usual split is that the sponsor funds the investigational drug and the protocol-mandated tests, while you carry travel, accommodation, caregiver time, lost income and any standard-of-care component outside the protocol.

The drug line is often the largest in lung cancer, since targeted and immunotherapy agents at commercial prices run into lakhs per month in India. How much a trial changes your total depends on what is covered, which arm you are allocated to, and what the protocol requires on top of routine care. Ask for an itemised written estimate and compare it against your current plan rather than assuming the saving.

What is routinely underestimated:

• Sequencing. An NGS panel is generally an upfront out-of-pocket cost, and you may need it before anyone can tell you whether you are eligible. Ask the trial team first: some protocols perform molecular testing inside screening, which can make a commercial panel unnecessary.
• Travel and accommodation during intensive monitoring. Early-phase protocols front-load visits. If the site is not in your city, this is usually the cost that ends a participation.
• Non-protocol supportive care. Antiemetics, growth factors, management of unrelated conditions.

Two things to ask for rather than assume. Reimbursement of travel and incidental expenses is permitted under ICMR's ethical guidelines with ethics committee approval, so request the study's written reimbursement policy. And Ayushman Bharat covers hospitalisation up to a per-family annual limit for eligible households, which may apply to standard-care components though not to personal travel; confirm with the hospital's counselling desk how it interacts with trial participation.

Rights people are not told about

Two entitlements are worth knowing before you sign.

Under India's New Drugs and Clinical Trials Rules, a participant injured in a clinical trial is entitled to free medical management, provided until the investigator judges it no longer necessary or the injury is established as unrelated to the trial, whichever comes first. Separately, financial compensation is payable for injury or death established as trial-related. The two are different entitlements with different tests. The consent documents should set them out and name who to contact; if they do not, ask before signing.

Withdrawal is permitted at any point and for any reason, and it must not be penalised or cost you care you would otherwise be entitled to. Ask in advance what the handover back to standard treatment involves and what it will cost, which is a separate question from the right to leave.

When an offer is not a trial

A few checks separate a registered study from something else using the word.

Ask for the CTRI registration number. A trial conducted in India must be registered before enrolling its first participant. If nobody can produce a number, or it does not resolve, this is not a registered trial. Treat the number as a starting check rather than a clearance, and also confirm the site, the investigator, the ethics committee and the regulatory permission.

You should not be paying for the investigational drug. In a sponsored trial the sponsor funds it. A fee to "enrol" you in exchange for experimental treatment is not how trials are funded.

There must be a named ethics committee. It need not belong to that hospital: where a site has no committee of its own, a registered independent committee may take responsibility for it, and the rules require that committee to be in the same city or within 50 km. Ask which committee approved the protocol and get the name in writing. Regulatory permission applies where required; some academic trials fall under a specific exemption, so ask which basis applies rather than assuming.

Written consent comes first. A participant information sheet in a language you read, time to consider it, and a signed copy you keep.

Nobody can promise an outcome. A protocol exists because the answer is not known. The same applies to anyone guaranteeing a place in a study.

How smoking history is used, and how it should not be

Two things often get tangled here, and the tangle affects decisions.

Smoking history correlates with tumour biology. Never-smokers more often carry EGFR and ALK alterations, which is why testing matters so much in that group. Tumours in people with a heavy smoking history tend to carry more mutations overall, which is part of why checkpoint inhibitors do more work there. A 2024 meta-analysis in Frontiers in Immunology of perioperative chemo-immunotherapy in resectable NSCLC found no statistically significant event-free-survival improvement in the never-smoker and EGFR-positive subgroups. That is a narrow finding about one setting and one endpoint, not a general verdict on immunotherapy, and subgroup analyses are not definitive. It is a reason to have the molecular result in hand before a regimen is chosen, and to ask how the evidence applies to your stage.

So smoking history is useful information for choosing a test and reading a result. It is not a reason for anyone to treat a patient as less deserving of a full workup, and if it ever feels like it is being used that way, that is a reason to get a second opinion rather than to accept a narrower plan.

Questions worth asking

1. What is my histology, and what did the full molecular panel show, including the specific variant and not just the gene?
2. If no driver was found, was the panel comprehensive, and was tissue adequate, or should it be repeated?
3. Is there an approved targeted drug for my alteration that should come before any trial?
4. Which trial supports the regimen you are proposing, and did it enrol patients at my stage with my alteration?
5. Is it open at a site I can reach, and is that site currently recruiting, not just the study overall?
6. What are the brain metastasis criteria?
7. If I progress, will we re-biopsy, and would the result change what we do?
8. What does the visit calendar look like, and what is the travel?
9. What is sponsor-funded, what is billed to me, and what is the written reimbursement policy?

Clear answers to all nine suggest the team has worked through your case in detail.

Where else to ask

The hospital's medical social work desk. Most large Indian cancer centres have one. They can help identify institutional charitable funds and the state schemes you may qualify for. What any given desk can actually fund varies, so confirm directly.

The study contact named on the registry entry. When a CTRI or ClinicalTrials.gov record names a contact, that is a legitimate route for a factual question about recruitment status. You do not need a referral to ask whether a site is still enrolling.

Patient organisations and peer networks. Useful on the practical texture of travel, visit schedules and dealing with a particular centre. Another person's experience is not evidence about your case, and no volunteer can assess your eligibility.

Limitations of this page

Recruitment status changes constantly, so every identifier here should be re-checked at source before you act on it. TROPION-Lung-14's status at any individual site in particular.

Centre descriptions come from each organisation's published material, checked in November 2026. Some entries here are deliberately narrower than descriptions you will find elsewhere, because claims we could not confirm against a primary source were cut rather than repeated.

Mutation frequencies vary by population and testing method, and we have not independently audited any centre's trial volume, accreditation or laboratory.

Frequently asked questions

Will I get a placebo instead of treatment? Very unlikely to be a placebo alone where effective treatment exists. The usual design compares a new agent added to standard care against standard care, sometimes placebo-controlled to blind it. Assume the control arm is possible and ask what it is.

Can I stay with my own oncologist while on a trial elsewhere? Usually yes, and it is sensible. Trial teams generally expect your primary oncologist to stay involved for anything outside the protocol's scope. Tell both sides.

What happens if the investigational drug does not work for me? The team reassesses: further treatment, another trial, or supportive care, depending on your condition and what you want. Ask in advance what the options would be, so the decision is not being made in a hurry.

Do I have to pay to be screened? Distinguish two things. Investigations you would have needed as routine care are billed as usual. Research-related procedures done only because of the study should not be charged to you: ICMR's ethical guidelines say participants should not bear research-related expenses beyond routine care, including work-up and investigations. Ask before the screening visit which category each test falls into, and what happens if you turn out to be ineligible.

Is there an upper age limit? Often not, but it is protocol-specific. Most adult protocols set a minimum age and lean on organ function and performance status at the other end.

Do brain metastases rule me out? Not necessarily, and lung cancer protocols vary more on this than on almost anything else. Some exclude them, some require them treated and stable for a defined period, some specifically study them. Ask about the protocol in front of you.

Should I stop my current treatment to become eligible? That is a decision for your treating oncologist and the trial investigator together, not one to make on your own. Eligibility is not a reason to interrupt treatment that is working.

Nothing here is advice about your treatment. No page can tell you whether a trial fits you. Take your genomic report, imaging and treatment timeline to a qualified oncologist and ask the eligibility questions directly.

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Reviewed 6 November 2026 by the India Cancer Guide editorial team. This article has not been reviewed by an independent clinician. Claims about organisations, trials and regulation are cited to primary sources or to the body's own published material, and our sourcing policy sets out how those are chosen. Recruitment status changes constantly; re-check any trial identifier at source before acting on it, and tell us if you find something stale and we will correct it and date the correction.