Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer

NCT03568097 | Unknown Phase 2

• 2 other identifiers: HE1/172017-004784-12
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

Brief Summary

PAVE(Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer) is a Greek, investigator- initiated, single arm open- label phase II study of Avelumab in combination with cisplatin or carboplatin/ etoposide. The study will include an initial safety run-in, open-label, singlearm part (Part 1), and the actual phase II study (Part 2). The total number of patients will not change (the safety run-in patients will be included in the final total number of participants). The safety run-in period will not alter the total study timelines, as phase II accrual will follow immediately after the safety run-in.

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1- year Progression Free Survival (PFS) Rate

  Efficacy of treatment for 1- year PFS according to RECIST v1.1

  Time from inclusion in the trial up to 12 months

Secondary Outcomes (9)

• Overall Survival Time (OS)

  Time from inclusion in the trial until the date of death due to any cause, up to 30 months.

• Best Overall Response (BOR).

  Time from inclusion in the trial up to 30 months.

• Objective Response Rate (ORR).

  Time from inclusion in the trial up to 30 months.

• Duration of Response (DOR) according to RECIST Version 1.1

  Time from inclusion in the trial up to 30 months.

• Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

  From the first dose of study drug treatment up to 90 days after the last dose of study drug administration

Study Arms (1)

Avelumab + Standard 1st line Chemotherapy

EXPERIMENTAL

Administration of cisplatin or carboplatin + etoposide every 3 weeks with phased avelumab administered every 2 weeks until disease progression.

Drug: Avelumab

Interventions

Avelumab DRUG

10 mg/kg will be given as intravenous infusion (IV) every two weeks (q 2 weeks) until disease progression.

Also known as: Bavencio

Avelumab + Standard 1st line Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• Male or female patients aged more than or equal to (≥) 18 years
• With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
• At least 1 measurable tumor lesion by RECIST 1.1
• With histologically confirmed metastatic (Stage IV) small cell lung cancer (SCLC)
• Patients must not have received any previous systemic treatment for small cell lung cancer
• Patients must have an estimated life expectancy of more than 12 weeks
• Patients must have an available recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy preferably within 6 months) or a minimum number of 10 unstained slides, suitable for PD-L1 expression assessment.

You may not qualify if:

• Patients with brain metastases are excluded, except those with brain metastases that have been treated with surgery or radiation and are clinically stable for at least 2 weeks prior to registration.
• Prior therapy with any antibody or drug targeting T cell co-regulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
• Patients on current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
• Known severe hypersensitivity reactions to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma, and persisting toxicity related to prior therapy of Grade \> 1 NCI-CTCAE v 4.03.
• Patients with active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
• Patients with prior organ transplantation including allogenic stem-cell transplantation are excluded.
• Patients with an active infection requiring systemic therapy are excluded.
• Patients with known history of testing positive for HIV or known acquired immunodeficiency syndrome are excluded.
• Also excluded are patients with Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
• Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
• Persisting toxicity related to prior therapy
• Other severe acute or chronic medical conditions.

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (6)

Attikon University Hospital

Chaïdári, Athens, 12462, Greece

Location

Agii Anargiri Cancer Hospital

Nea Kifissia, Athens, 14564, Greece

Location

Metropolitan Hospital

Neo Faliro, Athens, 18547, Greece

Location

Patra University Hospital

Rio, Patra, 26504, Greece

Location

Henry Dunant Hospital Center

Athens, 115 26, Greece

Location

Alexandra Hospital

Athens, 11528, Greece

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

avelumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Helena Linardou, MD

  1st Department on Medical Oncology, Metropolitan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 26, 2018
• Study Start: September 16, 2018
• Primary Completion: March 30, 2022
• Study Completion: April 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

GR (6)