Actively Recruiting
ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)
Led by Second Xiangya Hospital of Central South University · Updated on 2026-03-09
70
Participants Needed
20
Research Sites
220 weeks
Total Duration
On this page
Sponsors
S
Second Xiangya Hospital of Central South University
Lead Sponsor
N
Nanjing Shihejiyin Technology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The CR1STAL-Adaptive study is a randomized, open-label, phase II multicenter interventional trial designed to evaluate the safety and efficacy of Ivonescimab (PD-1/VEGF bispecific antibody) combined with docetaxel versus standard treatment in patients with advanced NSCLC who have achieved long-term benefit from first-line immune checkpoint inhibitors (ICIs), but are ctDNA-MRD positive. Building upon insights from previous CR1STAL study (NCT05198154), the CR1STAL-Adaptive study supports the development of precision-guided, adaptive treatment strategies to delay progression and improve outcomes in NSCLC patients with a long-term response to immunotherapy. It represents a step forward in integrating dynamic molecular monitoring with individualized intervention strategies in the era of immunotherapy.
CONDITIONS
Official Title
ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to comply with study visits and tests
- Age between 18 and 75 years
- ECOG performance status 0-1
- Expected survival of at least 12 weeks
- Confirmed stage IIIB, IIIC, or IV non-small cell lung cancer not eligible for local treatment
- No EGFR-sensitive mutation, ALK fusion, or ROS1 fusion in non-squamous carcinoma
- Previous first-line standard treatment with immunotherapy plus platinum-containing chemotherapy
- Non-progressive disease with progression-free survival of 11 to 15 months at screening
- At least one measurable lesion or documented disease progression by RECIST 1.1 criteria
- Asymptomatic or stable brain metastases after local treatment with specific conditions
- Adequate laboratory values for blood counts, liver, kidney, coagulation, and cardiac function
- Negative pregnancy test for women of childbearing potential and use of contraception during and after treatment
- Male participants must use effective contraception during and after treatment
You will not qualify if you...
- Participation in another interventional clinical trial or investigational drug use recently
- Use of systemic anti-tumor proprietary Chinese medicines or immunomodulators within 2 weeks
- No measurable lesions due to prior radical treatments
- Prior systemic antiangiogenic therapy
- Tumors with high risk of bleeding or invading vital organs increasing risk
- Active autoimmune disease requiring recent systemic treatment
- Major cardiovascular, liver, pulmonary, or metabolic diseases within the past year
- Recent gastrointestinal perforation, obstruction, or major surgery
- Recent radiotherapy with unresolved toxicity
- Recent live vaccines or severe infections
- History of bleeding disorders or recent significant bleeding
- Immunodeficiency or positive HIV test
- Active hepatitis B or C infection
- Active tuberculosis or syphilis infection
- Allergy to study drugs or severe hypersensitivity to monoclonal antibodies
- Use of long-term systemic corticosteroids or immunosuppressants
- History of mental illness, substance abuse, or uncontrolled toxicity from previous cancer treatments
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Other active malignancies unless in complete remission
- Pregnancy or breastfeeding
- Other illnesses or laboratory abnormalities increasing risks or interfering with study participation
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Hunan Cancer Hospital
Changsha, China, 410011
Not Yet Recruiting
2
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Actively Recruiting
3
The Third Hospital of Changsha
Changsha, China, 410011
Not Yet Recruiting
4
Xiangya Hospital of Central South University
Changsha, China, 410011
Not Yet Recruiting
5
Changsha Central Hospital
Changsha, China
Not Yet Recruiting
6
The First Hospital of Changsha
Changsha, China
Not Yet Recruiting
7
The Third Xiangya Hospital of Central South University
Changsha, China
Not Yet Recruiting
8
Army Medical Center (Daping Hospital)
Chongqing, China
Not Yet Recruiting
9
Guiyang Public Health Clinical Center
Guiyang, China
Not Yet Recruiting
10
Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong, China
Not Yet Recruiting
11
Kiang Wu Hospital, Macao
Macao, China
Not Yet Recruiting
12
The First Affiliated Hospital of Nanchang University
Nanchang, China
Not Yet Recruiting
13
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Not Yet Recruiting
14
Liaoning Cancer Hospital and Institute
Shenyang, China
Not Yet Recruiting
15
Shanxi Bethune Hospital
Taiyuan, China
Not Yet Recruiting
16
Hubei Cancer Hospital
Wuhan, China
Not Yet Recruiting
17
Renmin Hospital of Wuhan University
Wuhan, China
Not Yet Recruiting
18
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Not Yet Recruiting
19
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Not Yet Recruiting
20
Zhuzhou Central Hospital
Zhuzhou, China
Not Yet Recruiting
Research Team
F
Fang Wu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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