2026-10-01
Notable
Trial sites expanded: 53 → 65 locations
Primary completion pushed: 2031-12 → 2036-11
Eligibility criteria+38 characters
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status [...] od and prior to dosing of study treatment on Cycle 1 Day 1.
* Must consent to provide recently obtained formalin-fixed, pa [...] ion. c-Met IHC results are required prior to randomization.
* Must have at least one non-irradiated measurable disease per [...] sied within 14 days of the baseline tumor assessment scans.
* Any toxicities from prior systemic anti-cancer therapy must [...] ents (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy).
* Should not have any major, life-threa [...] [...]
Secondary endpointsdetails revised at 8 of 11 entries
2026-06-04
Minor
Study Status, Contacts/Locations v34
2026-06-03
Minor
Study Status, Contacts/Locations v33
2026-05-19
Minor
Study Status, Contacts/Locations v32
Trial sites expanded: 48 → 53 locations
2026-05-11
Minor
Study Status, Contacts/Locations v31
2026-05-11
Minor
Study Status, Contacts/Locations v30
2026-04-13
Minor
Study Status, Contacts/Locations v29
Completion pushed: 2031-12 → 2036-11
2026-04-02
Notable
Study Status, Contacts/Locations v28
Trial sites expanded: 43 → 46 locations
Primary completion moved earlier: 2036-11 → 2031-12
Completion moved earlier: 2036-11 → 2031-12
2026-03-19
Minor
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v27
Primary completion date2031-12→2036-11
Completion date2031-12→2036-11
Enrollment target694→854
Study sites41→43
InterventionsOsimertinib (Osi) (Drug), Standard of Care (Drug), Telisotuzumab Adizutecan (Drug)→Carboplatin (Drug), Cisplatin (Drug), Osimertinib (Osi) (Drug), Pemetrexed (Drug), Standard of Care (Drug), Telisotuzumab Adizutecan (Drug)
Eligibility criteria+1,136 characters
[...] determined by the investigator should be at least 3 months.
No prior estimated glomerular filtration rate (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 m [...] Exclusion Criteria:
History of interstitial lung disease (IL [...] ic pneumonitis.
Participants has leptomeningeal disease, or subjectparticipant has spinal cord compression not definitively treated with surgery or radiation.
History of any malign [...] [...]
Secondary endpoints11 entries, revised
PhaseStage 21: PFS based on BICR assessment per RECIST version 1.1.
PhaseStage 21: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.
PhaseStage 21: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.
PhaseStage 21: Overall Survival
PhaseStage 32: Overall Survival
PhaseStage 32: OR based on BICR assessment per RECIST version 1.1.
PhaseStage 32: DoR based on BICR assessment per RECIST version 1.1.
PhaseStage 32: DC based on BICR assessment per RECIST version 1.1.
PhaseStage 32: Change from baseline at Week 12 in physical functioning as [...] ncer Quality [...]
Primary endpoints3 entries, revised
PhaseStage 21: Objective Response (OR) Based on Blinded Independent Centr [...] se Evaluation Criteria in Solid Tumors (RECIST) version 1.1
PhaseStage 32: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
2026-01-21
Minor
Study Status, Contacts/Locations v26
2026-01-20
Minor
2 amendments v24-v25
2 re-verifications since 2026-01-15, no change to tracked fields
2025-12-23
Minor
Study Status, Contacts/Locations v23
2025-12-22
Minor
2 amendments v21-v22
2 re-verifications since 2025-12-21, no change to tracked fields
2025-12-18
Minor
Study Status, Contacts/Locations v20
2025-12-12
Minor
Study Status v19
Re-verified, no change to tracked fields
2025-12-04
Minor
Study Status, Contacts/Locations v18
2025-11-27
Minor
Study Status, Contacts/Locations v17
2025-11-21
Minor
Study Status, Contacts/Locations v16
2025-11-12
Minor
Study Status, Contacts/Locations v15
2025-11-08
Minor
Study Status, Contacts/Locations v14
2025-11-05
Minor
Study Status, Contacts/Locations v13
2025-11-01
Minor
Study Status, Contacts/Locations v12
2025-10-31
Minor
Study Status, Contacts/Locations v11
2025-09-22
Minor
Study Status, Contacts/Locations v10
2025-09-22
Minor
Study Status, Contacts/Locations v9
2025-09-18
Minor
Study Status, Contacts/Locations v8
2025-09-15
Minor
Study Status, Contacts/Locations v7
2025-09-05
Minor
Study Status, Contacts/Locations v6
2025-08-29
Minor
Study Status, Contacts/Locations v5
2025-08-27
Minor
Study Status, Contacts/Locations v4
2025-08-22
Minor
Study Status v3
Re-verified, no change to tracked fields
2025-08-19
Notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-08→confirmed 2025-08-03
Study sites0→6
2025-05-27
Minor
Original filing