MC1923 Phase II Clinical Trial of Durvalumab (MEDI4736) and Lurbinectedin in Patients With Relapsed Extensive Stage Small Cell Lung Cancer Previously Treated With Chemotherapy and Immunotherapy
Overview
- Phase
- Phase 2
- Intervention
- Durvalumab
- Conditions
- Platinum-Resistant Lung Small Cell Carcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- 6-month progression-free survival rate
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This phase II trial studies the effects of durvalumab and lurbinectedin in treating patients with extensive stage small cell lung cancer that has come back (relapsed) or has not responded to previous treatment with chemotherapy and immunotherapy (refractory). Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Lurbinectedin is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving durvalumab and lurbinectedin may help kill more tumor cells and help patients live longer.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate whether the combination of durvalumab with lurbinectedin can increase the 6-month progression-free survival in patients with extensive stage small cell lung cancer who have progressed after initial combination of chemotherapy and immunotherapy. (Group A and B) SECONDARY OBJECTIVES: I. To describe the safety and adverse event profile of each treatment group in patients with extensive stage small cell lung cancer who have progressed after initial combination of chemotherapy and immunotherapy. II. To assess in a preliminary fashion antitumor efficacy of this approach by assessing overall survival, progression-free survival, and response rate for each treatment group. CORRELATIVE RESEARCH OBJECTIVE: I. Blood and tissue will be banked for future studies. OUTLINE: Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients without disease progression are followed up at 30 days, every 6 weeks until disease progression, and then every 3 months thereafter for up to 5 years from enrollment. After completion of study treatment, patients with disease progression are followed every 3 months for up to 5 years from enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>= 18 years
- •Histological or cytological confirmation of small cell lung cancer
- •Prior treatment requirements:
- •Relapsed or progressed after only one prior chemotherapy and PD-1 or PD-L1 inhibitor regimen
- •Prior therapy must have been an etoposide platinum doublet combined with PD-1 or PD-L1 inhibitor
- •Group 1: Must have "platinum-sensitive" disease according to the following definitions:
- •"Sensitive" disease: Relapse occurred \> 90 days after completion of prior therapy
- •"Resistant" Disease: Relapse occurred =\< 90 days after completion of prior therapy
- •Group 2: May have "platinum sensitive" (Group 2A) or "platinum resistant" (Group 2B) disease
- •Measurable disease
Exclusion Criteria
- •Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- •Pregnant persons
- •Nursing persons
- •Persons of childbearing potential OR able to father a child who are unwilling to employ adequate contraception
- •Any of the following prior therapies:
- •Live vaccine \< 30 days prior to registration, including intranasal flu vaccine (e.g. Flu-Mist\[R\]) (Note: Injected seasonal influenza vaccine is not "live")
- •Surgery \< 28 days prior to registration
- •Chemotherapy or targeted small molecule therapy \< 21 days prior to registration
- •Radiation therapy \< 21 days prior to registration
- •Investigational therapy or investigational device \< 14 days prior to registration
Arms & Interventions
Group A (platinum sensitive; progression >3 months)
Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Durvalumab
Group A (platinum sensitive; progression >3 months)
Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Lurbinectedin
Group B (platinum refractory; progression >= 3 months)
Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Durvalumab
Group B (platinum refractory; progression >= 3 months)
Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Lurbinectedin
Outcomes
Primary Outcomes
6-month progression-free survival rate
Time Frame: At 6 months
The proportion of successes for 6-month PFS rate will be estimated by the number of successes divided by the total number of evaluable patients. Ninety percent confidence intervals for the true success proportion will be calculated according to the exact binomial method.
Secondary Outcomes
- Response rate(Up to 5 years)
- Progression-free survival (PFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
- Incidence of adverse events (AEs)(Up to 30 days post treatment)