To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS.
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|ClinicalTrials.gov Identifier: NCT04985851|
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : November 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Extensive-Stage Small-Cell Lung Cancer||Drug: durvalumab + anlotinib Drug: Durvalumab||Not Applicable|
Target subject population Adult patients (aged ≥18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC [T any, N any, M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have World Health Organization/Eastern Cooperative Oncology Group performance status of 0-1, weight > 30 kg and adequate organ and marrow function. All patients are suitable for firstline platinum-based chemotherapy.
Duration of treatment Unless specific treatment discontinuation criteria are met, patients in Arms 1 and 2 will continue therapy until disease progression, as per investigator assessment. Investigational product, dosage and mode of administration Durvalumab 1500 mg will be administered for all patients via IV infusion concurrently with EP q3w starting on week 0 for 4 cycles. Non-PD patients who completed the 4 cycles of Durvalumab + EP will be randomized 1:1 into Arm 1 and Arm 2. Eligible patients should begin continuous treatment in 3 days after randomization.
- Arm 1: Durvalumab 1500 mg monotherapy will be continued q4w. Anlotinib will be administered according to prescribing information in general use. The dose is 12mg, QD, PO, 14 days-on and 7 days-off.
- N.B. If a patient's weight falls to 30 kg or below (≤30 kg) the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab until the weight improves to >30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500 mg. Anlotinib is available at three dose levels, 12 mg, 10 mg, and 8 mg. Dose reduction may take place whenever toxicity that is not controlled with optimal supportive care is noted during the study. If a subject subsequently tolerates treatment well at that level in the judgment of the investigator, the dose may be increased to the next dose level. If a subject cannot tolerate treatment after dose reduction to 8 mg, treatment will be discontinued.
- Arm 2: Durvalumab 1500 mg monotherapy will be continued q4w.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an open-label, randomised, multicenter, Phase II study. This study is planned to enroll 80 eligible patients to receive durvalumab combined with up to 4 cycles of etoposide and platinum-based chemotherapy (EP). And approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease. Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Durvalumab (MEDI4736) Combined With Anlotinib Versus Durvalumab (MEDI4736) Alone as Maintenance Therapy in Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)|
|Actual Study Start Date :||September 28, 2021|
|Estimated Primary Completion Date :||June 1, 2024|
|Estimated Study Completion Date :||December 1, 2024|
Experimental: maintenance treatment durvalumab + anlotinib
Durvalumab 1500 mg monotherapy will be continued q4w. Anlotinib will be administered according to prescribing information in general use. The dose is 12mg, QD, PO, 14 days-on and 7 days-off.
Drug: durvalumab + anlotinib
Approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease.
Active Comparator: maintenance treatment durvalumab
Durvalumab 1500 mg monotherapy will be continued q4w.
- PFS-Progression Free Survival [ Time Frame: 2 years ]The time from the start of systemic treatment date to the date of first documented disease progression (event: disease progression - DP, based on RECIST, death, adverse events, which provide to disqualification from further therapy).
- OS-Overall Survival [ Time Frame: 2 years ]The time from the start of systemic treatment date to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985851
|Contact: Baohui Hanemail@example.com|
|Contact: Bo Zhangfirstname.lastname@example.org|
|Shanghai Chest Hospital||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Baohui Han|
|Contact: Bo Zhang|