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New treatment option for Non Small Cell Lung Cancer
Official title ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)
ClinicalTrials.gov ID: NCT06951646
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Sign written informed consent prior to any study-related procedures, be willing and able to complete the visits, treatment regimen, and laboratory...
- Aged ≥18 and ≤75 years old;
- ECOG PS score 0-1;
- Expected survival time ≥ 12 weeks;
- Patients with stage IIIB-IIIC and IV non-small cell lung cancer confirmed by histology or cytology that cannot be treated locally (TNM lung cancer...
You likely can't join if
- Concurrent participation in another treatment clinical study or receipt of another investigational drug, unless participating in an observational...
- Systemic therapy with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thiopeptides, interferons...
- No measurable lesions as defined by RECIST 1.1 due to prior radical treatment (e.g., surgery or radiotherapy)
- people who have received systemic antiangiogenic therapy;
- people who are enrolled in another clinical study at the same time, unless it is a non-treatment clinical study or the follow-up period of an...
- During the screening period, imaging shows that the tumor surrounds important blood vessels or there is significant necrosis or cavity, and the...
See the full eligibility criteria
Who can join
- Sign written informed consent prior to any study-related procedures, be willing and able to complete the visits, treatment regimen, and laboratory tests specified in the schedule, and comply with other requirements of...
- Aged ≥18 and ≤75 years old;
- ECOG PS score 0-1;
- Expected survival time ≥ 12 weeks;
- Patients with stage IIIB-IIIC and IV non-small cell lung cancer confirmed by histology or cytology that cannot be treated locally (TNM lung cancer staging of the 9th edition of the International Association for the...
- There must be no EGFR gene-sensitive mutation, ALK gene fusion or ROS1 gene fusion in non-squamous carcinoma
- Immunotherapy combined with platinum-containing doublet chemotherapy as a first-line standard treatment regimen;
- Non-PD with PFS at screening enrollment is 11 to 15 months;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), it is recommended to have at least one measurable lesion, but patients without measurable lesions can still be included in the group...
- There are measurable lesions outside the central nervous system
- No central nervous system symptoms or no worsening of symptoms for at least 2 weeks
- No need for glucocorticoid treatment, or glucocorticoid treatment was discontinued within 7 days before the first dose, or the glucocorticoid dosage was stable and reduced to less than 10mg/day prednisone (or equivalent...
- Routine blood test: absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin content ≥9.0 g/dL (no blood transfusion or erythropoietin-dependent administration within 7 days).
- Liver function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); for patients with liver metastasis or confirmed/suspected Gilbert's syndrome, TBIL ≤3×ULN; in the absence of liver metastasis, alanine...
- Renal function: serum creatinine (Cr) ≤ 1.5 times ULN or Cr clearance ≥ 50 mL/min (Cockcroft-Gault formula), and urine routine test results show urine protein (UPRO) \<2+ or 24-hour urine protein quantification \<1g.
- Coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN or partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; if the study participants are receiving...
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% 11. For female study participants of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days before...
What rules you out
- Concurrent participation in another treatment clinical study or receipt of another investigational drug, unless participating in an observational clinical study；
- Systemic therapy with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thiopeptides, interferons, interleukins, except those used locally for the control of hydrothorax or...
- No measurable lesions as defined by RECIST 1.1 due to prior radical treatment (e.g., surgery or radiotherapy)
- people who have received systemic antiangiogenic therapy;
- people who are enrolled in another clinical study at the same time, unless it is a non-treatment clinical study or the follow-up period of an treatment study (defined as the time between the first dose of this study and...
- During the screening period, imaging shows that the tumor surrounds important blood vessels or there is significant necrosis or cavity, and the investigator determines that entering the study will cause a risk of...
- Imaging findings during the screening period show that the tumor invades important peripheral organs and blood vessels (such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or there is...
- Active autoimmune diseases requiring systemic treatment (such as treatment with disease-modifying drugs, corticosteroids, and immunosuppressants) within 2 years before the first dose (excluding irAEs caused by the use...
- A history of major diseases within 1 year before the first dose, specifically:
- Unstable angina, myocardial infarction, congestive heart failure (NYHA classification ≥ Class 2) or vascular diseases (such as aortic aneurysm with a risk of rupture) that require hospitalization within 12 months before...
- Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh class B or more severe cirrhosis
- Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy;
- Hyperglycemia that cannot be controlled after treatment (fasting blood glucose \> 10 mmol/L);
- A history of esophageal and gastric varices, with severe ulcers and unresolved wounds, abdominal fistulas, intraabdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose;
- Any arterial thromboembolic events, venous thromboembolic events of grade 3 orabove as specified in NCI CTCAE 5.0, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive...
- Acute exacerbation of chronic obstructive pulmonary disease that occurred within 4 weeks before the first dose;
- Active or prior history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);
- A history of gastrointestinal perforation and/or fistula, a history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), or extensive bowel resection (partial...
- Those who have received chest radiotherapy \>30 Gy within 6 months before the first dose, non-chest radiotherapy \>30 Gy within 4 weeks before the first dose, and palliative radiotherapy ≤ 30 Gy within 2 weeks before...
- Those who have received live or live attenuated vaccines within 4 weeks before the first dose, or plan to receive live or live attenuated vaccines during the study period. The use of inactivated vaccines is allowed;
- Severe infections within 4 weeks before the first dose, including but not limited to complications requiring hospitalization such as sepsis, or severe pneumonia; active infections that have received systemic...
- Those with a history of severe bleeding tendencies or coagulation disorders; those with clinically significant bleeding symptoms within 4 weeks before the first dose, including but not limited to gastrointestinal...
- Those who have undergone major surgery or experienced severe trauma within 4 weeks before the first dose, or have a major surgery planned within 4 weeks after the first dose (as determined by the investigator);
- Presence of clinically uncontrolled pleural effusion or ascites (people may be recruited who do not require drainage of the effusion or who do not have a significant increase in the effusion after 3 days of cessation of...
- Previous history of non-infectious pneumonia requiring systemic glucocorticoid treatment or current interstitial lung disease;
- Those with a history of immunodeficiency; those with positive HIV antibody tests;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- people with untreated active hepatitis B (HBsAg positive and HBV-DNA \> 1000 copies/mL (200 IU/mL) or above the lower limit of detection, whichever is higher), for people with hepatitis B who are required to receive...
- Known presence of active pulmonary tuberculosis (TB);
- Known active syphilis infection;
- Known allergy to any component of any study drug; a known history of severe hypersensitivity to other monoclonal antibodies
- Those with a history of immunodeficienc; those who are currently receiving long-term systemic corticosteroids or other immunosuppressants;
- A known history of mental illness, drug abuse, alcohol or drug addiction;
- The toxicity of previous anti-tumor therapy has not been relieved, which is defined as the toxicity has not returned to grade 1 or below specified in NCI CTCAE 5.0, or the level specified in the inclusion/exclusion...
- Known symptomatic CNS metastases and/or carcinomatous meningitis. people with previously treated brain metastases may be enrolled in the trial if they are clinically stable (no evidence of imaging progression for at...
- History of other primary malignancies within 5 years, except：
- malignancies that have been in complete remission for at least 2 years prior to enrolment and for which no other treatment was required during the study period.
- adequately treated non-melanoma skin cancer or malignant nevus with no evidence of disease recurrence.
- adequately treated carcinoma in situ without evidence of disease recurrence
- people who are pregnant or breastfeeding or plan to breastfeed during the study;
- Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory test values that could increase the risks associated with study participation or study drug administration or interfere with the...
- Uncontrolled metabolic disorders, or local or systemic diseases due to non-malignant tumors, or diseases or symptoms secondary to the tumor, which may lead to higher medical risk and/or uncertainty in survival...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, China
- Chongqing, China
- Guiyang, China
- Hong Kong, China
- Macao, China
- Nanchang, China
- Nanning, China
- Shenyang, China
- Taiyuan, China
- Wuhan, China
- Xinxiang, China
- Zhuzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, China; Chongqing, China; Guiyang, China; Hong Kong, China; Macao, China; Nanchang, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.