Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy versus Standard of Care for 1st Line Treatment of Patients with Advanced Non-Small-Cell Lung Cancer - MADeIT

• Conditions: Patients with untreated advanced stage NSCLC.2:1 randomization to experimental (A) or standard arm (B). In arm A, treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level and will consist of gemcitabine and carboplatin (GC), docetaxel and carboplatin (DC), gemcitabine and docetaxel (GD), or docetaxel and vinorelbine (DV).In arm B, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin (GC) (standard of care).; MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB; MedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV

• Registration Number: EUCTR2008-000617-30-DE
• Lead Sponsor: Klinik Loewenstein gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-26
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

- Histologically confirmed NSCLC of adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or NSCLC not otherwise specified (NOS). Patients with suspected NSCLC may enroll prior to the diagnostic biopsy in order to obtain both the diagnostic and molecular analysis-required specimen during the same procedure.
- Willing to undergo a biopsy to enable customization of chemotherapy
- Stage IV or IIIB (malignant pleural effusion) NSCLC
- Measurable or evaluable disease by RECIST (Therasse et al, JNCI 2000)
- Age >= 18 years
- Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a complete surgical resection (R0 resection) for a NSCLC.
- Patients with stable brain metastases will be allowed to enroll.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or lactating women
- Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
- Prior malignancies, except: cured non-melanoma skin cancer; curatively treated in situ carcinoma of the cervix; any other curatively treated malignancy with no evidence of disease recurrence for at least 3 years
- peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v3.0 except if due to trauma
- patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified