18 and older, any sex, with Advanced Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0Primary· Randomization to measured progressive disease or treatment discontinuation up to 39.49 months
G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their
Group
Value
95% CI
Pemetrexed + Carboplatin
3.91
2.73 – 4.37
Paclitaxel + Carboplatin + Bevacizumab
2.86
2.20 – 4.30
Progression Free Survival (PFS)Secondary· Randomization to measured progressive disease up to 39.49 months
PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD was ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Group
Value
95% CI
Pemetrexed + Carboplatin
4.44
4.21 – 5.32
Paclitaxel + Carboplatin + Bevacizumab
5.45
5.03 – 5.95
Overall Survival (OS)Secondary· Randomization to date of death from any cause up to 39.49 months
OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.
Group
Value
95% CI
Pemetrexed + Carboplatin
10.51
9.26 – 11.96
Paclitaxel + Carboplatin + Bevacizumab
11.66
9.17 – 14.32
Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)Secondary· Baseline to date of objective progressive disease up to 39.49 months
Overall Response rate (ORR) was the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by th
Group
Value
95% CI
Pemetrexed + Carboplatin
23.6
17.7 – 30.5
Paclitaxel + Carboplatin + Bevacizumab
27.4
21.0 – 34.5
Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)Secondary· Baseline to date of objective progressive disease up to 39.49 months
Disease control rate was the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate was calculated as a total number of participants with CR or PR
Group
Value
95% CI
Pemetrexed + Carboplatin
59.9
52.4 – 67.1
Paclitaxel + Carboplatin + Bevacizumab
57.0
49.4 – 64.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to Follow-up (up to 9 years).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 29 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00948675.