Phase 3
N=577
Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Metastatic Non-Squamous Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03906071 ↗Enrolled (actual)
577
Serious AEs
41.0%
Results posted
Jun 2024
Primary outcome: Primary: Overall Survival (OS) — 12.22; 10.58 Months — p=0.144
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Biological); Sitravatinib (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mirati Therapeutics Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
12.22; 10.58 | 0.144 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Event (TEAEs) |
280; 272; 214; 216; 126; 101 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation |
77; 44; 50; 74 | — |
| SECONDARY Number of Participants With Maximum Post Baseline Hematology Grade Results |
118; 27; 134; 146; 16; 80 | — |
| SECONDARY Number of Participants With Maximum Post Baseline Chemistry Grade Results |
106; 228; 151; 37; 10; 0 | — |
| SECONDARY Objective Response Rate (ORR) Per Central Radiographic Assessment |
15.6; 17.2 | — |
| SECONDARY Duration of Response (DOR) Per Central Radiographic Assessment |
7.43; 7.10 | — |
| SECONDARY Clinical Benefit Rate Per Central Radiographic Assessment |
75.5; 64.5 | — |
| SECONDARY Progression-Free Survival (PFS) Per Central Radiographic Assessment |
4.40; 5.42 | — |
| SECONDARY 1-Year Survival Rate |
50.18; 44.12 | — |
| SECONDARY Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score |
4.10; 2.75; 2.74; 5.78; 4.58; 7.92 | — |
| SECONDARY Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) |
-0.09; -0.05; -0.07; -0.10; -0.10; -0.15 | — |
| SECONDARY Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) |
-4.74; -3.77; -3.24; -5.12; -3.37; -8.72 | — |
| SECONDARY Sitravatinib Plasma Concentration by Time Point |
2.73201; 32.41228; 75.72754; 89.71667; 62.20483; 51.90238 | — |
Summary
This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
- Receipt of at least one but not more than two prior treatment regimens in the advanced setting
- Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
- Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
- Candidate to receive docetaxel as second or third line therapy
Exclusion Criteria
- Uncontrolled brain metastases
- Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
- Unacceptable toxicity with prior checkpoint inhibitor therapy
- Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
- Impaired heart function
Data sourced from ClinicalTrials.gov (NCT03906071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.