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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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\*
* Mixed histology NSCLC with both adenocarcinoma and squamous cell carcinoma components (adenosquamous carcinoma or any mixed NSQ- squamous tumor), regardless of the predominant component

  * determined by investigator as likely to influence the prognosis or management of mNSCLC

Where it's running

• Research Site
  Bad Homburg, Germany Recruiting
• Research Site
  Berlin, Germany Recruiting
• Research Site
  Bremen, Germany Recruiting
• Research Site
  Chemnitz, Germany Recruiting
• Research Site
  Cologne, Germany Recruiting
• Research Site
  Deggendorf, Germany Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• STRIDE combination in advanced liver cancer: a first-line look at tremelimumab plus durvalumab

  This study tests tremelimumab plus durvalumab as a first-line treatment in adults with advanced or unresectable hepatocellular carcinoma to see how it affects liver health, quality of life, effectiveness, and safety.

  Recruiting at 17 sites AstraZeneca · Ancona and 23 other locations · NCT07607769

• RBS2418 with tremelimumab and durvalumab for advanced unresectable liver cancer

  This trial will test whether adding RBS2418 to tremelimumab plus durvalumab helps adults with advanced, unresectable hepatocellular carcinoma.

  Recruiting at 4 sites Phase 2 Riboscience, LLC. · Baltimore, Maryland and 3 other locations · NCT07175441

• Celecoxib with durvalumab and tremelimumab for advanced liver cancer

  This phase II trial tests whether adding the oral drug celecoxib to the immunotherapy drugs durvalumab and tremelimumab helps people with advanced or metastatic liver cancer.

  Recruiting at 3 sites Phase 2 Emory University · Atlanta, Georgia and 3 other locations · NCT07174570

• Y-90 internal liver radiation followed by tremelimumab and durvalumab for liver cancer with portal vein thrombosis

  This will test whether Y-90 selective internal radiation (SIRT) followed by tremelimumab and durvalumab helps people with non-resectable hepatocellular carcinoma that involves the portal vein.

  Recruiting Phase 2 Center Eugene Marquis · Grenoble and 5 other locations · NCT07122089

• Radiation therapy followed by immune therapy and surgery for hepatocellular carcinoma

  This trial tests whether adding durvalumab and tremelimumab to radiation therapy before surgery helps people with resectable liver cancer.

  Recruiting Phase 3 Hamilton Health Sciences Corporation · Hamilton, Ontario and 1 other locations · NCT07027436

• Photon radiotherapy plus tremelimumab and durvalumab for intermediate or advanced hepatocellular carcinoma

  This trial tests whether adding targeted photon radiotherapy to tremelimumab plus durvalumab helps people with unresectable intermediate or advanced (BCLC B or C) hepatocellular carcinoma respond better to treatment.

  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan City, Taiwan · NCT06999707

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.