Small Cell Lung Cancer (SCLC)
Conditions
Brief summary
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Detailed description
This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).
Interventions
Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).
Sponsors
Alliance Foundation Trials, LLC.
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Body weight \>30 kg. * Must have a life expectancy of at least 12 weeks. * Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition. * Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment. * Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required. * No prior systemic therapies, for small cell lung cancer. * Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer. * ECOG performance status 0-1.
Exclusion criteria
* Patients who are receiving any other investigational agents. * Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer. * Prior treatment with durvalumab. * History of another primary malignancy except for: * Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Superficial bladder cancer without active disease after treatment. * Low grade prostate cancer without indication for active treatment. * Adequately treated carcinoma in situ without evidence of disease. * Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months. * Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication. * Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | 2 years | To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved overall survival (OS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. OS is measured in months from the time of surgery. |
| Safety of the regimen | 1 year | The frequency of grade 3+ treatment-related adverse events will be reported. |
Countries
United States
Contacts
CONTACTQuality Management and Compliance
STUDY_CHAIRChi-Fu Jeffrey Yang, MD
Massachusetts General Hospital
STUDY_CHAIRJacob Sands, MD
Dana-Farber Cancer Institute
PRINCIPAL_INVESTIGATOREvanthia Galanis, MD
Alliance Foundation Trials, LLC.
Outcome results
None listed