ClinicalTrials.gg
Not yet recruitingNCT07760519Updated Oct 30, 2026

A Multicenter Observational PMS Study Assessing Durvalumab Safety in Indian Adults With Resectable NSCLC

An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by AstraZeneca · Observational

Updated Oct 30, 2026Start date movedGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
78
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca — 25 open to participants now, 78 under way, 28 of them phase 3. Carcinoma, Non-Small-Cell Lung · AstraZeneca.

Planned enrollment
57th of 67
78 · median 350
Started
2026
with 7 others
Observational
67 of 209
10 open now
Primary completion
2030-04
later than 72 of 77 live
Registered
208th of 209
by date

Among the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, this one is the 57th largest by planned enrollment of the 67 observational ones that give a count, is one of 8 that started in 2026, is one of 67 observational ones, reaches primary completion later than 72 of the 77 other live ones, and was the 208th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

25 of the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

20 more — sign in →

By country, each count listing its studies:

All 25 open studies →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • Durvalumab
  • NSCLC
  • post marketing surveillance
  • Real-world
  • Observational
  • Indian
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  1. Presence of unresectable or 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 disease or with medical conditions that required systemic or
  6. Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
78 participants (estimated)
Patient registry
No

Interventions

  • OtherIMFINZI

    IMFINZI

This study also gives Durvalumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. 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)\*

    Time frame: 21 months

  2. 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.

    Time frame: 21 months

  3. Time to occurrence of first AEs and first SAEs

    Time to occurrence of first AEs and first SAEs

    Time frame: 21 months

  4. * PRAEs as assessed per the WHO-UMC criteria

    \* PRAEs as assessed per the WHO-UMC criteria

    Time frame: 21 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Apr 2030, 41 months later.

Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's planned 41 months is below that.

Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 30, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2026
First posted
Aug 12, 2026
StartEst.
Nov 30, 2026was Sep 2026
Primary completionEst.
Apr 30, 2030
CompletionEst.
Apr 30, 2030
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 30, 2026→Nov 30, 2026
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Start date Sep 30, 2026→Nov 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07760519
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Apr 30, 2030 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Oct 30, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion