Evaluating a new treatment for advanced non-squamous 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 study assesses the safety and effectiveness of Telisotuzumab Adizutecan combined with Budigalimab in adults with advanced or metastatic non-squamous non-small cell lung carcinoma (NSCLC) who have not received prior treatment. The trial is divided into two stages: the first focuses on determining the optimal dose of the investigational drugs, while the second involves multiple treatment groups receiving different doses. Participants will be monitored for adverse events and changes in disease activity throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.
* Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
* For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.
* For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
* Must have documented programmed death ligand 1 (PD-L1) status.
* For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.
* Must have adequate organ function.

Exclusion Criteria:

* Known uncontrolled metastases to the central nervous system.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

Where it's running

• Providence - St. Jude Medical Center /ID# 271414
  Fullerton, California, United States Recruiting
• FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
  Oxnard, California, United States Recruiting
• UCLA - Santa Monica /ID# 271690
  Santa Monica, California, United States Recruiting
• University Of Colorado - Anschutz Medical Campus /ID# 269069
  Aurora, Colorado, United States Recruiting
• Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
  Lone Tree, Colorado, United States Recruiting
• Mayo Clinic Hospital Jacksonville /ID# 275073
  Jacksonville, Florida, United States Recruiting

+77 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

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

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• Telisotuzumab Adizutecan with Gemcitabine and Nab-Paclitaxel in Pancreatobiliary Cancers

  This study tests whether adding telisotuzumab adizutecan to standard chemotherapy can help adults with pancreatobiliary cancers see a benefit.

  Recruiting at 7 sites Phase 2 AbbVie · Hattiesburg, Mississippi and 6 other locations · NCT07769502

• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

  This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.

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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.