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A non-randomized, open, Simon'soptimal2-stage study to evaluate the efficacy and safety of 6MW3211 in patients with advanced Lung Cancer who had failed therapy with PD-1/L1 Inhibitor.
36 to 64 patients with advanced lung cancer who failed pD-1 /L1 inhibitor treatment will be inrolled.
Cohort 1:20 to 33 patients with non-small cell lung cancer (NSCLC) Cohort 2:16 to 31 patients with small cell lung cancer (SCLC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6MW3211 | Experimental | 6MW3211injection,30mg/kg,Q2W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6MW3211 | Drug | 6MW3211 injection ,30mg/kg,iv drip,Q2W |
|
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| Measure | Description | Time Frame |
|---|---|---|
| ORR | The percentage of (PR+CR) after treatment to the total number of cases was calculated | up to 24mouths or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on |
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Inclusion Criteria:
cohort2:Extensive stage small cell lung cancer (ES-SCLC) confirmed byhistologically or cytologically 3.Patients who had failed therapy with PD-1/L1 Inhibitor. 4.≥5 slides of unstained tumor tissue should be provided 5.EGFR, ALK, ROS1 were negative 6.ECOG 0 or 1 7.At least one extracranial measurable target evaluated by RECIST1.1 8.Expected survival≥3 months 9.Suitable organs and hematopoietic functions 10.Women and men of reproductive age must agree to use effective contraception from the date of signing the informed consent until 6 months after the last administration of 6MW3211 injection, and women of reproductive age must have negative serum pregnancy test results within 7 days prior to administration.
11.Sign informed consent voluntarily
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Exclusion Criteria:
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