Can immunotherapy be safely used in early lung cancer? a Real-World study investigates
NCT ID NCT07760519
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This observational study follows Indian adults with resectable non-small cell lung cancer who are prescribed durvalumab as part of their routine care. The goal is to monitor how often patients experience serious side effects, including severe adverse events and other complications. By reviewing medical records, researchers aim to better understand the real-world safety of this immunotherapy in this specific population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (IMFINZI), an immunotherapy drug
- What this could lead to
- If this study shows durvalumab is safe in this population, it could support its wider use as a standard treatment for early-stage lung cancer in India.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove effectiveness. It only tracks safety in a small group, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Indian patients with previously untreated resectable (tumors ≥ 4 cm and/or node positive) NSCLC and with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements will be enrolled from a geographically representative population from clinics/ hospitals across the country. Resectable NSCLC patients whose treatment decision with Durvalumab has been made by their treating physician and meet the eligibility criteria will be invited to participate in the study.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with newly diagnosed previously untreated resectable NSCLC (tumors ≥ 4 cm and/or node positive) and no known EGFR mutations or ALK rearrangements prescribed with durvalumab as per local prescriber information. 2. Provision of signed, written and dated informed consent Exclusion Criteria: 1. Presence of unresectable or metastatic disease. 2. Prior treatment with durvalumab for any other indications 3. Requires concurrent treatment for cancers other than resectable NSCLC 4. Concurrently participating in any other clinical trial 5. Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants 6. Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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