IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: NSCLC (Non-small-cell Lung Cancer)

Treatments: Drug: Sintilimab; Drug: IBI310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05118334

CIBI310H201

Details and patient eligibility

About

This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

1. Aged ≥18 years;
2. ECOG 0 ~ 1;
3. Histologically /cytologically confirmed R/M NSCLC;
4. Adequate organ and bone marrow function;
5. Expected survival ≥12 weeks;
6. Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
7. Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
8. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion Criteria:

1. Had tumors other than NSCLC within the past 5 years.
2. Had allogeneic organ or stem cell transplantation.
3. The presence of uncontrolled life-threatening illness
4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
5. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
6. HIV positive.
7. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
8. Severe, uncontrolled medical conditions and infections.
9. At the same time using other test drugs or in other clinical trials.
10. Refusal or inability to sign informed consent to participate in the trial.
11. Other treatment contraindications.
12. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
13. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
14. Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab

Experimental group

Description:

The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Treatment:

Drug: IBI310

Drug: Sintilimab

IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab

Experimental group

Description:

The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W\*4cycles,and then Sintilimab 200 mg IV, Q3W single until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Treatment:

Drug: IBI310

Drug: Sintilimab

IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab

Experimental group

Description:

The test group will be treated with IBI310 1mg/kg IV, Q6W+ Sintilimab 200 mg IV, Q3Wuntil progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Treatment:

Drug: IBI310

Drug: Sintilimab

IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab

Experimental group

Description:

The test group will be treated with IBI310 0.5mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Treatment:

Drug: IBI310

Drug: Sintilimab