M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: M7824; Drug: Durvalumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Drug: Pemetrexed; Drug: Placebo; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03840902

MS200647_0005

2018-003265-34 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
• Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
• Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization.
• Adequate hematological, hepatic and renal function as defined in the protocol
• Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies

Exclusion criteria

• Participants with Mixed small cell with non-small cell lung cancer histology
• Recent major surgery within 4 weeks prior to entry into the study
• Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization
• Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
• Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 2 patient groups

cCRT plus M7824 followed by M7824

Experimental group

Description:

Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Radiation: Intensity Modulated Radiation Therapy (IMRT)

Drug: Carboplatin

Drug: Paclitaxel

Drug: M7824

Drug: Etoposide

cCRT plus placebo followed by durvalumab

Active Comparator group

Description:

Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.

Treatment:

Drug: Durvalumab

Drug: Cisplatin

Drug: Placebo

Drug: Pemetrexed

Radiation: Intensity Modulated Radiation Therapy (IMRT)

Drug: Carboplatin

Drug: Paclitaxel

Drug: Etoposide