NCT00076856 is a Phase 2 clinical trial of Temozolomide in Carcinoma, Non-Small-Cell Lung, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT00076856?

NCT00076856 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00076856?

Interventions in NCT00076856: Temozolomide.

What condition does NCT00076856 study?

NCT00076856 studies Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Brain Neoplasms.

Is NCT00076856 still recruiting?

NCT00076856 is currently completed. Last updated 9 May 2017.

Last reviewed 2017-05-09 · How we verify

NCT00076856

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

Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

Completed Phase 2 Last updated 9 May 2017

What this trial tests

Phase 2 trial testing Temozolomide in Carcinoma, Non-Small-Cell Lung in 95 participants. Completed in 31 March 2006.

Timeline

31 March 2004

Primary endpoint
31 March 2006

31 March 2006

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	31 March 2004
Primary completion	31 March 2006
Estimated completion	31 March 2006

Drugs / interventions tested

Temozolomide (temozolomide) — full drug profile →

Conditions studied

Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
Brain Neoplasms — all drugs for Brain Neoplasms →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

Publications & conference data

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

Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases.
Tsao MN, Lloyd N, Wong RK, Chow E, et al · · 2012 · cited 138× · PMID 22513917 · DOI 10.1002/14651858.cd003869.pub3
Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases.
Tsao MN, Xu W, Wong RK, Lloyd N, et al · · 2018 · cited 117× · PMID 29365347 · DOI 10.1002/14651858.cd003869.pub4
The role of chemotherapy in the management of newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline.
Mehta MP, Paleologos NA, Mikkelsen T, Robinson PD, et al · · 2010 · cited 107× · PMID 19960229 · DOI 10.1007/s11060-009-0062-7
The role of emerging and investigational therapies for metastatic brain tumors: a systematic review and evidence-based clinical practice guideline of selected topics.
Olson JJ, Paleologos NA, Gaspar LE, Robinson PD, et al · · 2010 · cited 26× · PMID 19957013 · DOI 10.1007/s11060-009-0058-3
Treatments for brain metastases from EGFR/ALK-negative/unselected NSCLC: A network meta-analysis.
Zhang C, Zhou W, Zhang D, Ma S, et al · · 2023 · cited 2× · PMID 36820064 · DOI 10.1515/med-2022-0574

Verify or expand the search:

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Trials testing the same drug.

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NCT06639607 — PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/Hi · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Carcinoma, Non-Small-Cell Lung

Currently open trials in the same condition.

NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
NCT07222566 — Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adu · Phase 3 · recruiting
NCT07230691 — A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-Wor · recruiting
NCT07509333 — MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients · NA · recruiting
NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · 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 NCT00076856 (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 Merck Sharp & Dohme LLC
Last refreshed: 9 May 2017

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/NCT00076856.

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