Clinical trial · Interventional
A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients
Post-marketing Clinical Trial of Induction Chemotherapy of Pemetrexed Plus Carboplatin Followed by Pemetrexed Maintenance Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer
NCT01020786CI-TRIAL-00011935completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Carboplatin
- description
- After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.
- interventionNames
- Drug: Pemetrexed
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
- timeFrame
- Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
- description
- PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDOkamoto I, Aoe K, Kato T, Hosomi Y, Yokoyama A, Imamura F, Kiura K, Hirashima T, Nishio M, Nogami N, Okamoto H, Saka H, Yamamoto N, Yoshizuka N, Sekiguchi R, Kiyosawa K, Nakagawa K, Tamura T. Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naive patients with advanced nonsquamous non-small-cell lung cancer. Invest New Drugs. 2013 Oct;31(5):1275-82. doi: 10.1007/s10637-013-9941-z. Epub 2013 Mar 10. PMID 23475281