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Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

NCT02049151•EMD Serono

View on ClinicalTrials.gov

Summary

This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent, before any trial-related activities are carried out
•Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan
•Prior concurrent CRT which is defined as follows:
•* Minimum of 2 cycles of platinum-based chemotherapy
•* Radiotherapy with a total tumor dose greater than equal to (\>=) 60 Gray and a single fraction dose \>= 1.8 Gray
•* Overlap of radiotherapy with minimum 2 cycles of platinum-based chemotherapy (one cycle is defined as either 3 or 4 weeks depending on the chemotherapy regimen). A deviation of 2 to 3 days from an exact overlap is acceptable. Purely radiosensitizing doses of chemotherapy are not acceptable (for example \[e.g.\], daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
•Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible.
•Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
•An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol
+1 more criteria

Exclusion Criteria

•Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT
•Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
•Metastatic disease
•Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry
•Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
•A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies
•Splenectomy
•Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
•Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization
•Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks prior to randomization
+11 more criteria

Locations (2)

Please Contact U.S. Medical Information Located in

Rockland, Massachusetts, United States

Please contact the Merck KGaA Communication Center Located in

Darmstadt, Germany

Key Dates

Start Date

March 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

August 23, 2017

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Tecemotide

DRUG

Placebo

DRUG

Cyclophosphamide (CPA)

DRUG

Saline (sodium chloride)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)