Phase 4
N=109
A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01020786 ↗Enrolled (actual)
109
Serious AEs
15.6%
Results posted
Mar 2012
Primary outcome: Primary: Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods — 5.6 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pemetrexed (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods |
5.6 | — |
| SECONDARY Overall Survival (OS) During the Induction and Maintenance Therapy Periods |
NA; 20.2 | — |
| SECONDARY Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods |
34.9; 72.5 | — |
| SECONDARY Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods |
0.0; 34.9 | — |
| SECONDARY Progression Free Survival (PFS) During the Maintenance Therapy Period |
3.9; 3.9 | — |
| SECONDARY Overall Survival (OS) During the Maintenance Therapy Period |
NA; NA | — |
| SECONDARY Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period |
3.3; 48.3 | — |
| SECONDARY Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period |
81.7 | — |
| SECONDARY Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period |
38.5 | — |
Summary
To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.
Eligibility Criteria
Inclusion Criteria
- Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease
- Clinical stage IIIB/IV or recurrent disease after surgery
- No prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
- Prior radiation therapy is allowed to less than 25% of the bone marrow
- Measurable disease as defined by response evaluation criteria in solid tumors (RECIST)
- The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Estimated life expectancy of at least 12 weeks
Exclusion Criteria
- Clinically significant third-space fluid collections
- Central nervous system disease other than stable and treated brain metastasis
- More than 3 weeks interval between the surgery and enrollment request date
- Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), for a 5 days period
- Unable or unwilling to take folic acid or vitamin B12 supplementation
- Unable to take corticosteroids.
- Serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
- Currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography (CT)
Data sourced from ClinicalTrials.gov (NCT01020786). 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.