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This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line therapy in patients with extensive-stage small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706+chemotherapy | Experimental | Participants received intravenous infusions of QL1706 5mg/kg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle for 4-6 cycles. On Days 2 and 3 of every 21-day cycle, etoposide 100 mg/m^2 was administered alone for 4-6 cycles. Thereafter, participants received maintenance QL1706 5mg/kg on Day 1 of every 21-day cycle until progressive disease, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1 | Up to approximately 2 years |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| Carboplatin |
| Drug |
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle for 4-6 cycles. |
|
| Etoposide | Drug | Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for 4-6 cycles. |
|
The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1
| Up to approximately 2 years |
| Duration of Progression-Free Survival (PFS) | The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1 | Up to approximately 2 years |
| Duration of Overall Survival (OS) | Baseline until death from any cause | Up to approximately 2 years and a half |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |