A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

Recruiting Phase 3 Interventional Study
Non-Small Cell Lung Carcinoma (NSCLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
246 (estimated)
Sponsor
Sinocelltech Ltd. · Industry
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About This Trial

This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the written informed consent form prior to screening. 2. Age ≥ 18 years, both male and female. 3. ECOG Performance Status score of 0 to 1. 4. An expected survival of ≥ 3 months. 5. Histologically or cytologically confirmed, unresectable locally advanced (Stag…
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