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A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer - Trial NCT06012435

Access comprehensive clinical trial information for NCT06012435 through Pure Global AI's free database. This Phase 3 trial is sponsored by Seagen Inc. and is currently Not yet recruiting. The study focuses on Carcinoma, Non-Small-Cell Lung. Target enrollment is 560 participants.

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NCT06012435
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06012435
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A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
A Randomized, Phase 3, Open-label Study to Evaluate SGN-B6A Compared With Docetaxel in Adult Subjects With Previously Treated Non-small Cell Lung Cancer

Study Focus

SGN-B6A

Interventional

drug

Sponsor & Location

Seagen Inc.

Timeline & Enrollment

Phase 3

Nov 30, 2023

Jan 31, 2029

560 participants

Primary Outcome

Overall Survival (OS),Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)

Summary

This clinical trial is studying non-small cell lung cancer (NSCLC). Participants in this
 study must have cancer that has spread through their body or can't be removed with surgery.
 Participants in this study must have been treated with no more than a platinum-based
 chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable
 genomic alterations must have had no more than 2 drugs for that genomic alteration, in
 addition to platinum-based chemotherapy.
 
 This clinical trial uses an experimental drug called SGN-B6A, which is a type of antibody
 drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This
 clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has
 been approved to treat non-small cell lung cancer. It is usually given to patients who
 previously received another anticancer treatment. In this study, one group of participants
 will get SGN-B6A on Days 1 and 8 during each 21-day-cycle. A second group of participants
 will get docetaxel on Day 1 during each 21-day cycle.
 
 This study is being done to see if SGN-B6A works better than docetaxel to treat participants
 with NSCLC. This study will also test what side effects happen when participants take these
 drugs. A side effect is anything a drug does to the body besides treating the disease.

ICD-10 Classifications

Carcinoma in situ: Bronchus and lung
Secondary malignant neoplasm of lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06012435

Non-Device Trial