ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

July 1, 2028

Study Completion Date

June 1, 2030

Conditions
Non Small Cell Lung CancerImmune Checkpoint Inhibitors (ICIs)
Interventions
DRUG

Ivonescimab plus docetaxel

"For ctDNA-positive patients, escalation treatment will be administrated~1. Ivonescimab: Intravenous infusion (IV), 20 mg/kg, Day 1, every 3 weeks (Q3W);~2. Docetaxel: IV, 75 mg/m², Day 1, Q3W (The investigator may adjust the chemotherapy dose and schedule based on the patient's tolerance during treatment.)~All enrolled participants will continue treatment until one of the following occurs, whichever comes first:~* The investigator determines that there is no longer clinical benefit (based on imaging assessments and clinical status)~* Unacceptable toxicity~* Completion of 24 months of treatment~* Other discontinuation criteria specified in the protocol are met."

OTHER

Standard Treatment

"For ctDNA-positive patients, continuing the original immunotherapy maintenance or immunotherapy combined with chemotherapy~• In the event of clinical progression, consider switching to treatment with Ivonescimab plus docetaxel, administered every 3 weeks."

Trial Locations (13)

410011

Hunan Cancer Hospital, Changsha

The Second Xiangya Hospital of Central South University, Changsha

The Third Hospital of Changsha, Changsha

Xiangya Hospital of Central South University, Changsha

Unknown

The First Hospital of Changsha, Changsha

Army Medical Center (Daping Hospital), Chongqicun

Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong

The First Affiliated Hospital of Guangxi Medical University, Kunming

The First Affiliated Hospital of Nanchang University, Nanchang

Liaoning Cancer Hospital and Institute, Shenyang

Hubei Cancer Hospital, Wuhan

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

All Listed Sponsors
collaborator

Akeso-Sino Pharma Co., Ltd.

UNKNOWN

collaborator

Nanjing Shihejiyin Technology, Inc.

INDUSTRY

lead

Second Xiangya Hospital of Central South University

OTHER