Trial · NCT01565538

Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

NCT01565538, Phase 2, Completed, Si-Yu Wang; results first posted 2014-09-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma. Trials, record NCT01565538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01565538

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
NCT number: NCT01565538
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: Si-Yu Wang
Conditions: Lung Cancer
Interventions: Erlotinib, Pemetrexed
First posted: 2012-03-28
Last updated: 2014-09-15
Results first posted: 2014-09-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival	From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary	Best Tumor Response	From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	Overall Survival	From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression-Free Survival	From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.	months	MEDIAN
SECONDARY	Best Tumor Response	From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.	participants	NUMBER
SECONDARY	Overall Survival	From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.	months	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival	Erlotinib		4.1	95% Confidence Interval 1.6 to 6.6	months
Progression-Free Survival	Pemetrexed		3.9	95% Confidence Interval 2.7 to 5.1	months
Best Tumor Response	Erlotinib	Objective response	12		participants
Best Tumor Response	Pemetrexed	Objective response	5		participants
Best Tumor Response	Erlotinib	No objective response	49		participants
Best Tumor Response	Pemetrexed	No objective response	57		participants
Overall Survival	Erlotinib		11.7	95% Confidence Interval 7.5 to 15.9	months
Overall Survival	Pemetrexed		13.4	95% Confidence Interval 9.2 to 17.7	months

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Erlotinib	61
Overall Study	STARTED	Pemetrexed	62
Overall Study	COMPLETED	Erlotinib	61
Overall Study	COMPLETED	Pemetrexed	62
Overall Study	NOT COMPLETED	Erlotinib	0
Overall Study	NOT COMPLETED	Pemetrexed	0

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Rash	Skin and subcutaneous tissue disorders	Erlotinib	33	61
other	Rash	Skin and subcutaneous tissue disorders	Pemetrexed	4	62
other	Diarrhea	Gastrointestinal disorders	Erlotinib	10	61
other	Diarrhea	Gastrointestinal disorders	Pemetrexed	2	62
other	Dry skin	Skin and subcutaneous tissue disorders	Erlotinib	3	61
other	Dry skin	Skin and subcutaneous tissue disorders	Pemetrexed	0	62
other	Pruritus	Skin and subcutaneous tissue disorders	Erlotinib	3	61
other	Pruritus	Skin and subcutaneous tissue disorders	Pemetrexed	0	62
other	Anorexia	Gastrointestinal disorders	Erlotinib	6	61
other	Anorexia	Gastrointestinal disorders	Pemetrexed	9	62

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Erlotinib
Total, all-cause mortality	Pemetrexed
Total, other adverse events	Erlotinib	45	61
Total, other adverse events	Pemetrexed	43	62
Total, serious adverse events	Erlotinib	0	61
Total, serious adverse events	Pemetrexed	0	62

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24481719	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Erlotinib vs Pemetrexed: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01565538

GET https://conductscience.org/api/trials/v1/NCT01565538/events?page=2

API reference For AI assistants