Phase 2
Completed N=133
Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00402051 ↗Enrolled (actual)
133
Serious AEs
38.5%
Results posted
Jan 2010
Primary outcomePrimary: Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) — 52.8; 39.3 percentage
Summary
This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) |
52.8; 39.3 | — |
| SECONDARY Overall Survival |
11.7; 8.9 | — |
| SECONDARY Number of Participants With Tumor Response (as Basis for Response Rate) |
21; 13; 31; 32; 7; 15 | — |
| SECONDARY Time to Treatment Failure (TTF) |
3.0; 3.4 | — |
| SECONDARY Pharmacology Toxicities |
29; 36; 8; 12; 11; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
- No previous systemic chemotherapy for this cancer
- At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
- Prior radiation therapy allowed but limited to <25% of the patient's bone marrow
Exclusion Criteria
- Serious concomitant systemic disorder or active infection
- Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
- Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
- Presence of clinically significant third-space fluid collections
Data sourced from ClinicalTrials.gov (NCT00402051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.