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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almonertinib combined with SHR-1701 | Experimental |
| |
| Almonertinib | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonertinib combined with SHR-1701 | Drug | Phase Ⅰb/Phase Ⅱ: SHR-1701: injection, intravenous infusion Almonertinib: tablets, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. | 12 months after the first medication for the last subject |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbo Liu | Contact | 0518-82342973 | yanbo.liu@hengrui.com | |
| Weixia Li | Contact | 0518-82342973 | weixia.li@hengrui.com |
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This study is a multicenter, open-label, dose-exploring, and efficacy expansion phase Ib/II study. The first phase explored two doses of SHR-1701 plus fixed dose of almonertinib to confirm RP2D. The second phase is for efficacy expansion through randomization.
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| Almonertinib | Drug | Phase Ⅱ: Almonertinib: tablets, oral |
|
| ORR |
| up to 3 years |
| DCR | Disease Control Rate, determined using RECIST v1.1 criteria | up to 3 years |
| DoR | Duration of Response, determined using RECIST v1.1 criteria | up to 3 years |
| DepOR | Depth of tumor remission, determined using RECIST v1.1 criteria | up to 3 years |
| PFS | Progression-Free-Survival, determined using RECIST v1.1 criteria | up to 3 years |
| OS | OS is the time interval from the date of randomization to death due to any reason or lost of follow-up | up to 5 years |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| C000718108 | aumolertinib |
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