Chemotherapy for Patients With Non-Small Cell Lung Cancer

Browse trials for

• Lung Neoplasms 7,243
• Carcinoma, Non-Small-Cell Lung 6,488

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  Pemetrexed

  Drug: pemetrexed

Interventions

• Drugpemetrexed

  500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity\* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease. \*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets \<50 x 10\^9/L; absolute neutrophil count \<1.0 x 10\^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade \>2; Skin Grade \>2; Serum bilirubin \>3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase \>10 x ULN; Other non-hematologic toxicities Grade \>2 (except nausea, vomiting).

  Also known as: LY231514, Alimta

Primary outcomes

1. Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])

   The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.

   Time frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

Secondary outcomes

1. Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])

   DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

   Time frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

2. Overall Survival

   Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.

   Time frame: baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)

3. Progression-Free Survival (PFS)

   Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.

   Time frame: baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

4. Duration of Response

   Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.

   Time frame: time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

5. Time to Treatment Failure

   Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.

   Time frame: baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

6. Time to Tumor Progression

   Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.

   Time frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

Baseline characteristics

10 further baseline measures are reported on the registry.