NCT00126581 is a Phase 2 clinical trial of Carboplatin in Lung Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT00126581?

NCT00126581 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00126581?

Interventions in NCT00126581: Carboplatin, Erlotinib, Erlotinib Hydrochloride, Paclitaxel.

What condition does NCT00126581 study?

NCT00126581 studies Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Malignant Pericardial Effusion, Malignant Pleural Effusion, Minimally Invasive Lung Adenocarcinoma, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7.

Is NCT00126581 still recruiting?

NCT00126581 is currently completed. Last updated 7 August 2019.

Are results published for NCT00126581?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-07 · How we verify

NCT00126581

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

Completed Phase 2 Results posted Last updated 7 August 2019

What this trial tests

Phase 2 trial testing Carboplatin in Lung Adenocarcinoma in 188 participants. Completed in 28 November 2017.

Timeline

15 August 2005

Primary endpoint
30 June 2010

28 November 2017

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	188
Start date	15 August 2005
Primary completion	30 June 2010
Estimated completion	28 November 2017
Sites	96 locations across United States

Drugs / interventions tested

Carboplatin (Carboplatin) — full drug profile →
Erlotinib (erlotinib) — full drug profile →
Erlotinib Hydrochloride
Paclitaxel — full drug profile →

Conditions studied

Lung Adenocarcinoma — all drugs for Lung Adenocarcinoma →
Lung Adenosquamous Carcinoma — all drugs for Lung Adenosquamous Carcinoma →
Malignant Pericardial Effusion — all drugs for Malignant Pericardial Effusion →
Malignant Pleural Effusion — all drugs for Malignant Pleural Effusion →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Lung Adenocarcinoma or Lung Adenosquamous Carcinoma. 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.

18 Weeks Progression Free Survival (PFS) Rate Primary · At 18 weeks

The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm. The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline me

Group	Value	95% CI
Arm A: Erlotinib	52	NA – NA
Arm B: Erlotinib/Carboplatin/Paclitaxel	69	NA – NA

Overall Response Rate Secondary · Duration of Study (up to 3 years)

The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions

Group	Value	95% CI
Arm A: Erlotinib	35	24 – 46
Arm B: Erlotinib/Carboplatin/Paclitaxel	46	36 – 56

Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. Secondary · Duration of study (up to 3 years)

The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.

Group	Value	95% CI
Arm A: Erlotinib	20
Arm B: Erlotinib/Carboplatin/Paclitaxel	52

Overall Survival Secondary · Time from randomization to death (up to 3 years)

Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Group	Value	95% CI
Arm A: Erlotinib	24.6	18.4 – 33.8
Arm B: Erlotinib/Carboplatin/Paclitaxel	19.8	14.4 – 27.8

Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status Secondary · Duration of treatment (up to 3 years)

PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure. EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and

EGFR Mutant

Group	Value	95% CI
Arm A: Erlotinib	14.1	7.0 – 19.6
Arm B: Erlotinib/Carboplatin/Paclitaxel	17.2	8.2 – 28.7

EGFR Wild Type

Group	Value	95% CI
Arm A: Erlotinib	2.6	1.4 – 3.9
Arm B: Erlotinib/Carboplatin/Paclitaxel	4.8	2.8 – 5.6

Overall Response Rate by EGFR Mutation Status Secondary · Duration of study (up to 3 years)

Response and EGFR mutation status are defined in previous outcome measures.

EGFR Mutant

Group	Value	95% CI
Arm A: Erlotinib	70	51 – 84
Arm B: Erlotinib/Carboplatin/Paclitaxel	73	18 – 44

EGFR Wild Type

Group	Value	95% CI
Arm A: Erlotinib	9	3 – 22
Arm B: Erlotinib/Carboplatin/Paclitaxel	30	18 – 44

Progression Free Survival With KRAS Mutation Status Secondary · Duration of study (up to 3 years)

Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.

Group	Value	95% CI
Mutant	4	2.8 – 12.4
Wild Type	6.7	5.3 – 8.0

Overall Response Rate With KRAS Mutational Status Secondary · Duration of study (up to 3 years)

Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.

Group	Value	95% CI
Mutant	29	10 – 56
Wild Type	42	34 – 51

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Erlotinib

Serious: 21/81 (26%)

Deaths: —

Arm B: Erlotinib/Carboplatin/Paclitaxel

Serious: 39/99 (39%)

Deaths: —

Serious adverse events (125 terms)

Reaction	System	Arm A: Erlotinib	Arm B: Erlotinib/Carboplat…
Fatigue	General disorders	—	—
Leukocytes (total WBC)	Investigations	—	—
Nausea	Gastrointestinal disorders	—	—
Hemoglobin	Blood and lymphatic system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Neutrophils/granulocytes (ANC/AGC)	Investigations	—	—
Rash: acne/acneiform	Skin and subcutaneous tissue disorders	—	—
Platelet count decreased	Investigations	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Glucose serum-high (hyperglycemia)	Metabolism and nutrition disorders	—	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—	—
Sodium serum-low (hyponatremia)	Metabolism and nutrition disorders	—	—
Albumin, serum-low (hypoalbuminemia)	Metabolism and nutrition disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Lymphopenia	Investigations	—	—
Calcium serum-low (hypocalcemia)	Metabolism and nutrition disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Rash/desquamation	Skin and subcutaneous tissue disorders	—	—
Thrombosis/thrombus/embolism	Vascular disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Magnesium serum-low (hypomagnesemia)	Metabolism and nutrition disorders	—	—

Other adverse events (207 terms — click to expand)

Reaction	System	Arm A: Erlotinib	Arm B: Erlotinib/Carboplat…
Fatigue	General disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Rash: acne/acneiform	Skin and subcutaneous tissue disorders	—	—
Leukocytes (total WBC)	Investigations	—	—
Hemoglobin	Blood and lymphatic system disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Neutrophils/granulocytes (ANC/AGC)	Investigations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Platelet count decreased	Investigations	—	—
Rash/desquamation	Skin and subcutaneous tissue disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Glucose serum-high (hyperglycemia)	Metabolism and nutrition disorders	—	—
Blood bilirubin increased	Investigations	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Albumin, serum-low (hypoalbuminemia)	Metabolism and nutrition disorders	—	—
Pain	Gastrointestinal disorders	—	—
Insomnia	Psychiatric disorders	—	—
Dysgeusia	Nervous system disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Potassium serum-low (hypokalemia)	Metabolism and nutrition disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Alkaline phosphatase	Investigations	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Creatinine	Investigations	—	—
Lymphopenia	Investigations	—	—
Magnesium serum-low (hypomagnesemia)	Metabolism and nutrition disorders	—	—
Infection	Infections and infestations	—	—
Sodium serum-low (hyponatremia)	Metabolism and nutrition disorders	—	—
Dizziness	Nervous system disorders	—	—
Mucositis/stomatitis (functional/symptomatic)	Gastrointestinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Calcium serum-low (hypocalcemia)	Metabolism and nutrition disorders	—	—
Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	—	—

Most-reported serious reactions: Fatigue, Leukocytes (total WBC), Nausea, Hemoglobin, Diarrhea, Peripheral sensory neuropathy, Neutrophils/granulocytes (ANC/AGC), Rash: acne/acneiform.

Data from ClinicalTrials.gov NCT00126581 adverse events section.

Sponsor's own description

This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Randomized phase II trial of erlotinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial.
Jänne PA, Wang X, Socinski MA, Crawford J, et al · · 2012 · cited 194× · PMID 22547605 · DOI 10.1200/jco.2011.40.1315
Delay of treatment change after objective progression on first-line erlotinib in epidermal growth factor receptor-mutant lung cancer.
Lo PC, Dahlberg SE, Nishino M, Johnson BE, et al · · 2015 · cited 37× · PMID 25876525 · DOI 10.1002/cncr.29397
Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review.
Chan SHY, Khatib Y, Webley S, Layton D, et al · · 2023 · cited 10× · PMID 37383708 · DOI 10.3389/fphar.2023.1137983
An updated network meta-analysis of EGFR-TKIs and combination therapy in the first-line treatment of advanced EGFR mutation positive non-small cell lung cancer.
Qi Y, Xia X, Shao L, Guo L, et al · · 2022 · cited 7× · PMID 35978809 · DOI 10.3389/fonc.2022.616546
The Landscape of Clinical Trials in Never-Smoker Non-Small-Cell Lung Cancer: Registered Evidence and Persistent Gaps
Ramos R, Sousa C, Vale N. · · 2026

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

NCT04832438 — 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma · Phase 2 · withdrawn
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting

Other recruiting trials for Lung Adenocarcinoma

Currently open trials in the same condition.

NCT07481786 — Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases · Phase 3 · recruiting
NCT07219251 — Engagement of Veterans With Lung Cancer · NA · recruiting
NCT07235280 — Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma · EARLY_PHASE1 · recruiting
NCT07161713 — SBU-RESET: RElaxation, Stress Reduction and Epigenetics Trial in Cancer Survivors · NA · recruiting
NCT07479095 — Low-glucose/High-fat Intake Dietary Regimen as a Tool for Empowering Diagnostic Accuracy of 2-[18F]FDG PET/CT in Lepidic · NA · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00126581 (US National Library of Medicine, public domain)
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 National Cancer Institute (NCI)
Last refreshed: 7 August 2019

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/NCT00126581.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing