Clinical trial · Interventional
Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Sacituzumab Govitecan-hziy (SG) | Drug | Sacituzumab Govitecan | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
- description
- Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
- interventionNames
- Drug: Sacituzumab Govitecan-hziy (SG)
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- SG + Pembrolizumab (Cohort B)
- description
- Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
- interventionNames
- Drug: Sacituzumab Govitecan-hziy (SG)
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator * No prior systemic treatment for metastatic NSCLC * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate hematologic counts * Adequate hepatic function Key Exclusion Criteria: * Mixed SCLC and NSCLC histology * Active second malignancy * NSCLC that is eligible for definitive local therapy alone * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has had an allogenic tissue/solid organ transplant. * Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient * Has received radiation therapy to the lung * Individuals may not have received systemic anticancer treatment within the previous 6 months * Is currently participating in or has participated in a study of an investigational agent * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Known active central nervous system (CNS) metastases * History of cardiac disease * Active chronic inflammatory bowel disease * Active serious infection requiring antibiotics * Active or chronic hepatitis B infection * Positive hepatitis C antibody * Positive serum pregnancy test or women who are lactating Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (1)
- DERIVEDReck M, Patel JD, Gray JE, Reguart N, Cobo M, Pradera JF, Felip E, Cappuzzo F, Garon EB, Neal JW, Mekan S, Safavi F, Fernando N, Zavodovskaya M, Jurgensmeier JM, Chisamore M, Cho BC. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study. J Thorac Oncol. 2026 Mar;21(3):103509. doi: 10.1016/j.jtho.2025.10.016. Epub 2025 Oct 30. PMID 41173143