Phase 3 Clinical Trial Of ANKTIVA Plus NIVOLUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer

Phase 3

Not yet recruiting

• Conditions: NSCLC, Stage III
• Interventions: Drug: ANKTIVA; Drug: Nivolumab; Drug: Docetaxel

• Registration Number: NCT06745908
• Lead Sponsor: ImmunityBio, Inc.

Brief Summary

This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of ANKTIVA plus nivolumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant randomization will be stratified by geographical re...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01
• Primary Completion: 2028-09
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	ANKTIVA	Treatment regimen will consist of 2, 3-week cycles followed by repeated 2-week cycles with a ± 3-day window for each visit. Agents are to be administered in the order listed (eg, on day 1 experimental arm \[cycles 1 and 2\], administer ANKTIVA, followed by nivolumab and then followed by docetaxel).
Experimental Arm	Nivolumab	Treatment regimen will consist of 2, 3-week cycles followed by repeated 2-week cycles with a ± 3-day window for each visit. Agents are to be administered in the order listed (eg, on day 1 experimental arm \[cycles 1 and 2\], administer ANKTIVA, followed by nivolumab and then followed by docetaxel).
Experimental Arm	Docetaxel	Treatment regimen will consist of 2, 3-week cycles followed by repeated 2-week cycles with a ± 3-day window for each visit. Agents are to be administered in the order listed (eg, on day 1 experimental arm \[cycles 1 and 2\], administer ANKTIVA, followed by nivolumab and then followed by docetaxel).
Control Arm	Docetaxel	The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV.

Primary Outcome Measures

Name	Time	Method
Compare Overall Survival between the experimental and control arms	Approximately 12 months