Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Pemetrexed

Erlotinib Hydrochloride

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm

Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Erlotinib

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

150 mg given po, QD, starting on the first day of the first cycle

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.

Per RECIST:

CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.

SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm\*100.

CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.

SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm\*100.

Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date.

OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.

Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.

Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Eli Lilly and Company

Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Pemetrexed (Nonsquamous and Squamous)

Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle

Pemetrexed + Erlotinib (Nonsquamous and Squamous)

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Pemetrexed (Nonsquamous)

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle

Pemetrexed + Erlotinib (Nonsquamous)

Pemetrexed (Squamous)

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle

Pemetrexed + Erlotinib (Squamous)

Total

Age Continuous

Sex: Female, Male

Caucasian

African

Hispanic

Native American

East Asian

West Asian

Race/Ethnicity, Customized

Austria

Germany

Spain

Hungary

Sweden

Region of Enrollment

Status 0

Status 1

Status 2

Unknown

Eastern Cooperative Oncology Group (ECOG) Performance Status classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

0 - Fully Active

1. - Ambulatory, Restricted Strenuous Activity
2. - Ambulatory, No Work Activities
3. - Partially Confined to Bed, Limited Self Care
4. - Completely Disabled

Eastern Cooperative Oncology Group (ECOG) Performance Status

Histopathological

Cytological

Basis for Diagnosis

Adenocarcinoma of the lung

Mixed cell (squamous/adenocarcinoma)

Large cell lung carcinoma

Bronchioalveolar carcinoma

Squamous cell carcinoma of the lung

Initial Pathological Diagnosis

Stage I

Stage II

Stage IIIA

Stage IIIB

Stage IV

Disease Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).

Stage 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver

Stage of Disease at Study Entry

Never smoked

Ex-smoker

Current smoker

Smoking status

Up to 15 pack-years

More than 15 pack-years

Pack-year equals the number of cigarette packs smoked per day multiplied by the number of years the participant has smoked. For example, 1 pack-year is equal to smoking an average of 20 cigarettes per day (1 pack) for 1 year.

Pack-years, smokers only

Baseline Characteristics are presented by histology (nonsquamous/squamous) for each arm. Per the protocol amendment of August 2008, study entry criteria were changed to exclude participants with predominantly squamous cell histology.

Chief Medical Officer

Includes Nonsquamous population only.

In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy.

In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy.

Progression Free Survival (PFS)

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)

Time to Treatment Failure (TTTF)

Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored

Overall Survival (OS)

Includes nonsquamous population only.

On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall.

Percentage of Participants Surviving at 1 Year

serious adverse events

other adverse events

All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.

Number of Participants With Adverse Events (AEs)

Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle

Spots Global Cancer Trial Database for histological or cytological diagnosis of locally advanced or metastatic nsclc of nonsquamous histology and not amenable to curative therapy.