Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer
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
390 (estimated)
Sponsor
3D Medicines (Sichuan) Co., Ltd. · Industry
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About This Trial

This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Volunteer to participate and sign the informed consent form. 2. Age ≥ 18 years old, regardless of gender. 3. Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC. 4. Measurable lesions based on the response evaluation criteria in solid tumors ver…
Contacts

Changli Wang

0086-22-2340123

Wangchangli@tjmuch.com

CONTACT