EVOKE-02: A phase 2 study of sacituzumab govitecan (SG) plus pembrolizumab (pembro) with or without platinum chemotherapy in first-line metastatic non–small cell lung cancer (NSCLC).
Bibliographic record
Abstract
TPS9146 Background: Most patients (pts) with advanced NSCLC do not harbor genomic alterations associated with approved first-line targeted therapies. The standard of care for these pts is a programmed death (ligand)-1 (PD-[L]1) inhibitor alone, if the tumor highly expresses PD-L1, or in combination with platinum doublet chemotherapy, independent of PD-L1 expression. However, most pts do not respond to these therapies or achieve only a transient response, highlighting an unmet need. SG is an antibody-drug conjugate composed of an anti–Trop-2 antibody coupled to the cytotoxic SN-38 payload via a proprietary, hydrolyzable linker. In the phase 1/2 IMMU-132-01 basket study (NCT01631552), SG demonstrated an objective response rate (ORR) of 17% and median overall survival (OS) of 9.5 mo, with a manageable safety profile in 54 pts with metastatic NSCLC after multiple prior therapies (Heist RS, et al. J Clin Oncol. 2017). We hypothesize that combining SG with pembro or with pembro + platinum chemotherapy will improve outcomes for pts with advanced NSCLC. Methods: EVOKE-02 (NCT05186974) is an open-label, multicenter, multicohort, global phase 2 study evaluating SG plus pembro with or without carboplatin (carbo) or cisplatin (cis) in advanced NSCLC. Key eligibility criteria include age ≥18 y, stage IV NSCLC at enrollment, measurable disease by RECIST v1.1, ECOG performance status of 0 or 1, and adequate organ function. Pts must not have actionable genomic alterations and must not have received prior systemic therapy for metastatic NSCLC. Up to 164 pts will be enrolled. SG plus pembro will be assessed in squamous/nonsquamous NSCLC with Tumor Proportion Score (TPS) ≥50% (cohort A, ̃30 pts) and TPS < 50% (cohort B, ̃30 pts), and SG plus pembro with carbo/cis in nonsquamous (cohort C, ̃40 pts) and squamous (cohort D, ̃40 pts) NSCLC regardless of PD-L1 expression. Pts are randomly assigned if cohorts enrolling concurrently have overlapping eligibility. SG will be administered intravenously (IV) at 10 mg/kg on d 1 and 8 until disease progression or unacceptable toxicity, pembro 200 mg IV on d 1 for up to 35 cycles, carbo AUC 5 or cis 75 mg/m2 on d 1 for up to 4 cycles in 21-d cycles. A safety run-in will be conducted for cohorts C and D (up to 24 pts each) to determine the optimal SG dose by dose de-escalation. Choice of platinum will be based on preliminary efficacy in safety run-in. The primary endpoints are ORR assessed by independent review per RECIST v1.1 and the incidence of dose-limiting toxicities per dose for the first 21 d of the safety run-in to determine the recommended phase 2 dose of SG in combination with pembro and a platinum. Key secondary endpoints include progression-free survival by independent review, OS, duration of response, disease control rate, and safety. This study is open for recruitment and is enrolling globally. Clinical trial information: NCT05186974.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".