Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer

Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy \>1 week, delay of pemetrexed/cisplatin Cycle 2 \>2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.

Time frame: Baseline to measured progressive disease (PD; up to 1 year)

Population: The treated population included all participants who received at least 1 dose of either study therapy (that is, pemetrexed, cisplatin, or radiation).

OS was defined as the time from date of enrollment to death due to any cause.

Time frame: Baseline to date of death from any cause (up to 1 year)

Population: The treated population was considered the primary analysis population for the efficacy endpoints. The efficacy analysis was also completed on the protocol-qualified (PQ)population to assess the sensitivity of the results.

A listing of AEs is located in the Reported Adverse Event module.

Time frame: Baseline to measured PD (up to 1 year)

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).

Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease \* 100, where objective responders are those participants who have met criteria either for CR or PR.

Time frame: Baseline to measured PD (up to 3 years)

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and with measurable disease.

OS was defined as the time from date of enrollment to death due to any cause.

Time frame: Baseline and 2 years and 3 years

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).

The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.

Time frame: Baseline and 1 year and 2 years and 3 years

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).

Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.

Time frame: Baseline to measured PD (up to 3 years)

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and who had PD.

Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.

Time frame: Baseline to measured PD (up to 3 years)

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eleven participants were censored.

PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).

Time frame: Baseline to measured PD (up to 36 months)

Population: The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eight participants were censored.