Conditions

Non Small Cell Lung Cancer

Keywords

Non-squamous

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
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.
Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)

Secondary Outcomes (8)

Overall Survival (OS) During the Induction and Maintenance Therapy Periods
Enrollment to the date of death from any cause (up to 30.8 months)
Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods
Enrollment to date of progressive disease (up to 18 months)
Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods
Enrollment to date of progressive disease (up to 18 months)
Progression Free Survival (PFS) During the Maintenance Therapy Period
From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)
Overall Survival (OS) During the Maintenance Therapy Period
From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)
+3 more secondary outcomes

Study Arms (1)

Pemetrexed + Carboplatin

EXPERIMENTAL

After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.

Drug: PemetrexedDrug: Carboplatin

Interventions

PemetrexedDRUG

Induction Therapy: 500 milligrams per square meter (mg/m\^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Maintenance Therapy: 500 mg/m\^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Also known as: Alimta, LY231514

Pemetrexed + Carboplatin

CarboplatinDRUG

Dosage equal to area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Pemetrexed + Carboplatin

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.