Carcinoma, Non-Small-Cell LungNCT07760519
A Multicenter Observational PMS Study Assessing Durvalumab Safety in Indian Adults With Resectable NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca.
Trial summary
This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- IMFINZI
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Provision of signed, written and dated informed consent
Who cannot join
- Presence of unresectable or metastatic disease.
- Prior treatment with durvalumab for any other indications
- Requires concurrent treatment for cancers other than resectable NSCLC
- Concurrently participating in any other clinical trial
- Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants
- Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to Assess Safety of Durvalumab in Indian Adult Patients With Resectable Non-Small Cell Lung Cancer (NSCLC)
This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- IMFINZI
- Keywords
- Durvalumab, NSCLC, post marketing surveillance, Real-world, Observational, Indian
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMFINZIOther
IMFINZI
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
Measured: 21 months
Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.
Frequency and proportion of patients with treatment emergent adverse events (TEAE) \& serious adverse events (SAEs), , mortality.
Measured: 21 months
Time to occurrence of first AEs and first SAEs
Time to occurrence of first AEs and first SAEs
Measured: 21 months
* PRAEs as assessed per the WHO-UMC criteria
- PRAEs as assessed per the WHO-UMC criteria
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760519
- Sponsor's protocol ID
- D9106R00007
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to Assess Safety of Durvalumab in Indian Adult Patients With Resectable Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07760519
- Acronym / sponsor ID
- D9106R00007
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Durvalumab, NSCLC, post marketing surveillance, Real-world, Observational, Indian
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
- Provision of signed, written and dated informed consent
Key exclusion criteria (6 listed)
- Presence of unresectable or metastatic disease.
- Prior treatment with durvalumab for any other indications
- Requires concurrent treatment for cancers other than resectable NSCLC
- Concurrently participating in any other clinical trial
- Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMFINZIIMFINZI | Other | – |
Primary outcome
Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
Time frame: 21 months
- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.
Time frame: 21 months
Frequency and proportion of patients with treatment emergent adverse events (TEAE) \& serious adverse events (SAEs), , mortality.
Time to occurrence of first AEs and first SAEs
Time frame: 21 months
Time to occurrence of first AEs and first SAEs
* PRAEs as assessed per the WHO-UMC criteria
Time frame: 21 months
* PRAEs as assessed per the WHO-UMC criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)* (time frame: 21 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.