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Examining the effectiveness of a treatment combination in patients with advanced lung cancer

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

AstraZeneca · NCT06494540

This study is testing a new treatment combination for patients with advanced lung cancer to see how well it works based on their specific genetic markers.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years to 120 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsdurvalumab, tremelimumab, chemotherapy
Locations23 sites (Bad Homburg and 22 other locations)
Trial IDNCT06494540 on ClinicalTrials.gov

What this trial studies

This observational study in Germany aims to gather real-life data on patients with non-squamous metastatic non-small cell lung carcinoma (mNSCLC) who are starting first-line treatment with a combination of tremelimumab, durvalumab, and platinum-based chemotherapy. The study will focus on understanding the effectiveness of this treatment in relation to specific genetic mutations and biomarkers, including KRAS, STK11, KEAP1, TP53, TTF-1, and PD-L1. By collecting and analyzing this data, the study seeks to enhance the understanding of biomarker-guided treatment strategies for patients with high medical needs in this cancer subtype.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with treatment-naïve, histologically confirmed non-squamous metastatic non-small cell lung carcinoma.

Not a fit: Patients with sensitizing EGFR mutations or ALK alterations may not benefit from this study as they are excluded from participation.

Why it matters

Potential benefit: If successful, this study could lead to more effective, personalized treatment strategies for patients with advanced lung cancer based on their genetic profiles.

How similar studies have performed: Other studies have shown promise in using biomarker-guided approaches for treating lung cancer, suggesting that this study's approach is both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Aged ≥ 18 years
* Decision to start first-line (1L) treatment with TDC according to the current SmPCs
* Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician)
* No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations
* Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53)
* TTF-1 expression analysis has been initiated
* PD-L1 expression analysis has been initiated
* Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab
* Ability to understand the study concept
* Provision of signed informed consent form in accordance with applicable local provisions

Exclusion Criteria:

* Current participation in interventional clinical trials
* Contraindications according to current SmPCs
* Any active tumor other than metastatic NSCLC

Where this trial is running

Bad Homburg and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-squamous Metastatic Non-Small-Cell Lung Carcinoma, NSCLC,, mNSCLC,, KRAS,, STK11,, KEAP1,, TP53,, POSEIDON,

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.