Clinical trial NCT05132413: A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer
Official title: A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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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:

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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.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
timeFrame: 2 years
measure: BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival (PFS)（Stage I）
timeFrame: 2 years
measure: Objective response rate (ORR)（Stage I）
timeFrame: 2 years
measure: Disease control rate (DCR) （Stage I）
timeFrame: 2 years
measure: Duration of response (DOR) （Stage I）
timeFrame: 2 years
measure: Overall survival (OS) （Stage I）
timeFrame: 2 years
measure: Progression free survival (PFS)（Stage II）
timeFrame: 2 years
measure: Objective response rate (ORR)（Stage II）
timeFrame: 2 years
measure: Disease control rate (DCR)（Stage II）
timeFrame: 2 years
measure: Duration of response (DOR) （Stage II）
timeFrame: 2 years
measure: Overall survival (OS) （Stage II）
timeFrame: 2 years
measure: Incidence and severity of adverse events (AEs), serious adverse events （Stage II）
timeFrame: 2 years
measure: (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: