Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population (INSPIRE)

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Single low dose cyclophosphamide; Other: Best Supportive Care (BSC); Other: Saline; Biological: Tecemotide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01015443

EMR63325-012

Details and patient eligibility

About

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of Asian subjects with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called placebo controlled study).

Enrollment: 285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC)
• Documented stable disease or objective response, according to Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST v1.0) after primary concomitant chemo-radiotherapy for unresectable stage III disease, within four weeks (28 days) prior to randomization
• Receipt of concomitant chemo-radiotherapy. The chemotherapy-part must have been platinum-based, must have been administered with a minimum of two cycles overlap with radiotherapy (one cycle lasts either 3 or 4 weeks depending on the chemotherapy regimen), and a minimum of two platinum-based chemotherapy administrations must have been given during radiotherapy. Purely radio sensitizing doses of chemotherapy are not acceptable. Radiotherapy must have delivered a radiation dose of >= (greater than or equal to) 50 Gray (Gy). Induction or consolidation chemotherapy is allowed and if given, should be accounted as part of primary thoracic chemoradiotherapy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible
• Geographically accessible for ongoing follow-up, and committed to comply with the designated visits
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• A platelet count >= the lower limit of normal for the site or >= 100 x 10^9 per liter (/Liter) (whichever is greater); white blood cell (WBC) >= 2.5 x 10^9/Liter and haemoglobin >= 90 gram per liter (g/L)
• >=18 years of age (or minimum age of legal consent consistent with local regulations, if minimum is greater than [>] 18 years of age)
• Other protocol defined inclusion criteria could apply

Exclusion criteria

Pre-Therapies*:

• Prior sequential chemo-radiotherapy
• Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy
• Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GMCSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within four weeks (28 days) prior to randomization
• Investigational systemic drugs (including off-label use of approved products) within four weeks (28 days) prior to randomization

Disease Status:

• Metastatic disease
• Malignant pleural effusion at initial diagnosis 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
• Autoimmune disease
• A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
• Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
• Known active Hepatitis B infection and/or Hepatitis C infection
• Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such

Physiological Functions:

• Clinically significant hepatic dysfunction
• Clinically significant renal dysfunction
• Clinically significant cardiac disease
• Splenectomy
• Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response

Standard Safety:

• Pregnant or breastfeeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
• Known drug abuse or alcohol abuse
• Participation in another clinical trial (excluding purely observational studies) within the past 28 days
• Requires concurrent treatment with a non-permitted drug
• Known hypersensitivity to any of the trial treatment ingredients
• Legal incapacity or limited legal capacity
• Any other reason that, in the opinion of the investigator precludes the subject from participating in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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285 participants in 2 patient groups, including a placebo group

Investigational Arm

Experimental group

Description:

Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)

Treatment:

Biological: Tecemotide

Drug: Single low dose cyclophosphamide

Other: Best Supportive Care (BSC)

Control Arm

Placebo Comparator group

Description:

Saline + Placebo + Best supportive care (BSC)

Treatment:

Drug: Placebo

Other: Best Supportive Care (BSC)

Other: Saline