NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Prospective Non-interventional Study (NIS) to Examine the Effectiveness of Tremelimumab + Durvalumab + Platinum Chemotherapy (TDC) in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

ClinicalTrials.gov ID

NCT06494540

Acronym / sponsor ID

NAUTIC / D419MR00003

Conditions

Non-squamous Metastatic Non-Small-Cell Lung Carcinoma

Keywords

NSCLC,, mNSCLC,, KRAS,, STK11,, KEAP1,, TP53,, POSEIDON,, Tremelimumab,

Study type

Observational

Recruitment status

Recruiting

Enrolment

600 participants (estimated)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Study start

28 Jun 2024 (actual)

Primary completion

31 Dec 2029 (estimated)

Study completion

31 Dec 2029 (estimated)

First posted

10 Jul 2024 (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.

Study design

Observational model

Cohort

Time perspective

Prospective

Who may qualify

Ages

18 to 120 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Adult patients (≥18 years) with a histologically or cytologically confirmed NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician), planned treatment initiation with TDC according to applicable Summary of product characteristics (SmPCs) within routine clinical practice and initiated molecular gene panel analysis (including KRAS, STK11, KEAP1, and TP53) as well as PD-L1 and TTF-1 expression analyses are eligible for enrolment. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions but no later than 21 days after application of the first TDC treatment cycle.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population

   Time frame: Time from patient's index date until death by any cause, up to 24 months

   rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in the total study population. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.

2. Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS

   Time frame: Time from patient's index date until death by any cause, up to 24 months

   rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in KRAS. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.

3. Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11

   Time frame: Time from patient's index date until death by any cause, up to 24 months

   rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in STK11. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.

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 28 Sep 2026.
• Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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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.

30 sites in 1 country: see every site and its status.