A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer

Suzhou Suncadia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

Treatments: Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin; Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin; Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05132413

SHR-1701-III-310

Details and patient eligibility

About

Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs

Enrollment: 561 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A subject must satisfy all of the following criteria to be considered for inclusion in the study:

1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
2. Failed with prior EGFR-TKIs treatments.
3. Measurable disease, as defined by RECIST v1.1
4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion criteria

A subject who meets any of the following criteria will be excluded from study entry:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Symptomatic, untreated or active central nervous system metastases.
3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
4. With any active autoimmune disease or history of autoimmune disease.
5. Inadequately controlled hypertension.
6. Tumour infiltration into the great vessels on imaging.
7. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
8. Uncontrolled tumour-related pain.
9. Patients with active hepatitis B or hepatitis C
10. Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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561 participants in 3 patient groups, including a placebo group

treatment group

Experimental group

Treatment:

Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab

Placebo group 1

Placebo Comparator group

Treatment:

Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin

Placebo group 2

Placebo Comparator group

Treatment:

Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin