Phase 2
Completed N=106
A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00606021 ↗Enrolled (actual)
106
Serious AEs
9.3%
Results posted
Dec 2011
Primary outcomePrimary: Progression Free Survival During Maintenance Phase — 3.2; 3.2 months — p=0.1815
Summary
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival During Maintenance Phase |
3.2; 3.2 | 0.1815 |
| SECONDARY Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP]) |
6.2; 6.0 | 0.1233 |
| SECONDARY Overall Survival During Maintenance Phase |
12.2; 11.8 | 0.7239 |
| SECONDARY Overall Survival During Overall Period (IP + MP) |
15.4; 16.4 | 0.6376 |
| SECONDARY Number of Participants With Adverse Events (AEs) During Overall Period |
15; 16; 74; 1; 1; 13 | — |
| SECONDARY Tumor Response Rate and Disease Control Rate After Induction Phase (IP) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- You must be at least 18 years old
- You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
- You must have had no prior systemic anticancer therapy for lung cancer
- You must live close enough to the study doctor to be able to visit regularly for follow up
- You must have signed informed consent form indicating your willingness to take part in this study
- Your laboratory and medical history and tests must meet study requirements
Exclusion criteria
- Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
- Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
- Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
- Brain metastasis
- Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
- Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
- Concurrent administration of any other antitumor therapy
- Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
- Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
- Pregnancy or breast-feeding
- You are allergic to pemetrexed
Data sourced from ClinicalTrials.gov (NCT00606021). 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.