Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Almonertinib combined with SHR-1701
|
Drug: Almonertinib combined with SHR-1701
Phase Ⅰb/Phase Ⅱ：
SHR-1701: injection, intravenous infusion
Almonertinib: tablets, oral
|
| Placebo Comparator: Almonertinib
|
Drug: Almonertinib
Phase Ⅱ:
Almonertinib: tablets, oral
|
Outcome Measures
Primary Outcome Measures
- Dose limiting toxicity （Phase Ib） [21 days after the first dose]
- The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib） [from the time when all informed subjects signed the informed consent to the end of the safety follow-up period]
- PFS rate at 12 months [12 months after the first medication for the last subject]
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Secondary Outcome Measures
- Adverse Events and Serious Adverse Events [up to 3 years]
- Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial [up to 3 years]
- ORR [up to 3 years]
- DCR [up to 3 years]
Disease Control Rate, determined using RECIST v1.1 criteria
- DoR [up to 3 years]
Duration of Response, determined using RECIST v1.1 criteria
- DepOR [up to 3 years]
Depth of tumor remission, determined using RECIST v1.1 criteria
- PFS [up to 3 years]
Progression-Free-Survival, determined using RECIST v1.1 criteria
- OS [up to 5 years]
OS is the time interval from the date of randomization to death due to any reason or lost of follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients voluntarily joined the study and signed informed consent
-
Age 18~75 years old, both male and female
-
Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
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At least one measurable lesion based on RECIST v1.1 criteria
-
ECOG PS score: 0-1
-
Have a life expectancy of at least 3 months
-
Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating
Exclusion Criteria:
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Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
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Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
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Suffering from other malignant tumors in the past 3 years or at the same time
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Presence of any active or known autoimmune disease
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Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (randomization)
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Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk
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Have clinical symptoms or diseases of the heart that are not well controlled
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Patients with hypertension who are not well controlled by antihypertensive medication
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Any bleeding event of grade 2 or more or hemoptysis (volume of hemoptysis ≥2ml in a single episode) occurring within 2 weeks before the first dose (randomization); Clinically significant bleeding symptoms or definite bleeding tendency before the first medication (randomization)
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Have known history of serious infections within 1 month prior to the first dose(randomization), including but not limited to infectious complications that require hospitalization, bacteremia, and severe pneumonia; use antibiotics within 1 week prior to the first dose(randomization); have any active infections requiring intravenous systemic therapy, or have a fever > 38.5°C of unknown cause before the first dose(randomization).
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Have active or prior documented interstitial pneumonia/interstitial lung disease or pneumonitis that requires glucocorticoid treatment (e.g., radiation pneumonitis); Have active pneumonia at present
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Have active pulmonary tuberculosis.
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Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.
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Had received lung radiation therapy within 6 months before the first dose (randomization); Had received major surgical treatment (except diagnostic surgery), systemic chemotherapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first medication (randomization); Received palliative radiotherapy within 2 weeks before the first dose (randomization); Oral administration of molecular targeted drugs, less than 5 half-lives before discontinuation of the drug to the first dose (randomization); Failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE grade≤1
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1701-215