A Study of Durvalumab Plus Tremelimumab With Chemotherapy in Untreated ES-SCLC

NCT03963414 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 0275-19-FB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and tolerability of durvalumab and tremelimumab in combination with intravenous (IV) carboplatin plus (+) etoposide in new patients with extensive-stage small cell lung cancer (ES-SCLC).

Conditions

Small Cell Lung Carcinoma

Keywords

Extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-related Adverse Events with a Severity of 3 or higher (Safety and tolerability)

  Evaluate the safety and tolerability profile of durvalumab + tremelimumab in combination with carboplatin and etoposide in ES-SCLC and PS2. Adverse events with a severity grade of 3 or higher per CTCAE guidelines will be used to assess this outcome.

  3 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Durvalumab 1500 mg via IV infusion every 3 weeks, starting on Week 7, for up to a maximum of 2 doses/cycles followed by durvalumab maintenance monotherapy 1500 mg via IV infusion every 4 weeks, starting 4 weeks after Cycle 4.

Combination Product: Durvalumab in combination with carboplatin and etoposide

Cohort 2

EXPERIMENTAL

Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion every 3 weeks, starting on Week 7, for up to a maximum of 2 doses/cycles followed by durvalumab monotherapy 1500 mg via IV infusion every 4 weeks, starting 4 weeks after the last infusion of the combination.

Combination Product: Durvalumab + Tremelimumab in combination with carboplatin and etoposide

Interventions

Durvalumab + Tremelimumab in combination with carboplatin and etoposide COMBINATION_PRODUCT

1500mg of durvalumab plus 75mg of tremelimumab in combination with carboplatin and etoposide will be given every 3 weeks for Cycles 3 and 4. 1500mg of durvalumab plus 75mg of tremelimumab will be given every 3 weeks for Cycles 5 and 6.

Also known as: MEDI4736

Cohort 2

Durvalumab in combination with carboplatin and etoposide COMBINATION_PRODUCT

1500mg of durvalumab in combination with carboplatin and etoposide will be given every 3 weeks for Cycles 3 and 4.

Also known as: MEDI4736

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old at time of study entry (consent) and adult male or female (For Nebraska, ≥19 years old)
• Histologically or cytologically confirmed ES-SCLC
• Tumor biopsy or cytology should be obtained within 8 weeks of initiation of treatment.
• Brain metastases; must be asymptomatic or treated and stable, off steroids for at least 1 month prior to study treatment.
• Have not received any prior therapy for SCLC, except palliative radiation. If the patient received radiation, there must be measurable disease outside the radiation field.
• Measurable disease or evaluable disease based on RECIST Version 1.1.
• Eastern Cooperative Oncology Group ECOG = 2
• Body weight \> 30 kg
• No active secondary malignancy. Patients with other prior malignancies will be included, provided they have been disease-free for at least five years.
• Adequate hematologic and end organ function
• Women of childbearing potential must have a pregnancy test (urine or serum) proven negative within 14 days prior to registration.

You may not qualify if:

• Participation in another clinical study with an investigational product during the last 28 days.
• Any previous chemotherapy and /or immunotherapy for SCLC
• Current or prior use (≤ 14 days before first doses of study drugs) of immunosuppressive medication.
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
• History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP
• History of leptomeningeal carcinomatosis
• Paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic steroids or clinical symptomatology suggesting worsening of PNS
• Active infection including tuberculosis, HIV, hepatitis B and C.
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled cardiovascular disease
• History of active primary immunodeficiency
• Pregnant or lactating women
• Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Sponsors & Collaborators

• University of Nebraska: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab; tremelimumab; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Apar Ganti, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 24, 2019
• Study Start: September 25, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)