OncoMatch/Clinical Trials/NCT07005102
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Is NCT07005102 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for non-squamous non-small cell lung cancer.
Treatment: Standard of Care · Telisotuzumab Adizutecan · Osimertinib (Osi) · Cisplatin · Carboplatin · Pemetrexed — Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide. In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations
Required: EGFR L858R
documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations
Required: MET expression (IHC testing required for stratification; no eligibility threshold specified)
c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.
Disease stage
Metastatic disease required
metastatic/locally advanced non-squamous NSCLC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Exception: prior EGFR TKI in adjuvant setting allowed if >= 126 months since last dose before Cycle 1, Day 1
No prior EGFR tyrosine kinase inhibitor (TKI) in the locally advanced and/or metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that >= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC Norris Comprehensive Cancer Center /ID# 275343 · Los Angeles, California
- Usc Norris Oncology/Hematology Treatment Center /ID# 278673 · Newport Beach, California
- University Colorado Cancer Center /ID# 275382 · Aurora, Colorado
- Mid Florida Hematology And Oncology Center /ID# 275278 · Orange City, Florida
- The Iowa Clinic /ID# 276020 · West Des Moines, Iowa
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify