Concurrent Peme...
  Short Summary
    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.
    Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if
2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment;
concurrent pemetrexed intravenous (IV) bolus with doses escalating from
300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days
1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts
1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4.
    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.
    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.
  Full Summary
    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 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.
    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 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).
    Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if
2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment;
concurrent pemetrexed intravenous (IV) bolus with doses escalating from
300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days
1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts
1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4.
    Participants then received 2 additional consolidation cycles repeated every
3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2
IV. Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then
75 mg/m^2 IV, q21 days x 2 cycles.
    Patient must have been diagnosed with non-small cell lung cancer.
  patient (100)
    Patient must have been diagnosed with non-small cell lung cancer.
  treatment (84)
    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 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.
    Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if
2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment;
concurrent pemetrexed intravenous (IV) bolus with doses escalating from
300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days
1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts
1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4.
  disease (76)
    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.
    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 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).
  response (69)
    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.
  pemetrexed/cisplatin (61)
    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.
  target lesions (53)
    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.
  progression (53)
    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.
    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 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).
  cycles (53)
    Participants then received 2 additional consolidation cycles repeated every
3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2
IV. Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then
75 mg/m^2 IV, q21 days x 2 cycles.
  sum (46)
    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.
  concurrent (46)
    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.
    Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if
2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment;
concurrent pemetrexed intravenous (IV) bolus with doses escalating from
300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days
1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts
1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4.
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