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Evaluating a new treatment for advanced non-squamous lung cancer

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Phase1; Phase2 Interventional AbbVie · NCT06772623

This study is testing a new combination of medications for adults with advanced lung cancer who haven't had treatment before, to see if it is safe and effective.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment252 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, Telisotuzumab, budigalimab, pembrolizumab
Locations64 sites (Fullerton, California and 63 other locations)
Trial IDNCT06772623 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic non-squamous NSCLC who have not received prior systemic therapy and have no actionable genomic alterations.

Not a fit: Patients with uncontrolled metastases to the central nervous system or a history of interstitial lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-squamous NSCLC.

How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapy and targeted treatments, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Fullerton, California and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

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 → Find more trials like this →
Conditions Non Small Cell Lung CarcinomaPembrolizumabPemetrexedCarboplatinCisplatinTelisotuzumab AdizutecanABBV-400ABBV-181
Last reviewed 2026-06-13 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.