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NCT02444741
Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Phase 1, PHASE2 trial testing 3-Dimensional Conformal Radiation Therapy in Malignant Solid Neoplasm in 126 participants. Participants enrolled and being followed up; not accepting new ones.
30 September 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 126 |
| Start date | 17 September 2015 |
| Primary completion | 30 September 2026 |
| Estimated completion | 30 September 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 3-Dimensional Conformal Radiation Therapy
- Intensity-Modulated Radiation Therapy
- Laboratory Biomarker Analysis — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
- Proton Beam Radiation Therapy
- Radiation Therapy — full drug profile →
- Stereotactic Body Radiation Therapy — full drug profile →
Conditions studied
- Malignant Solid Neoplasm — all drugs for Malignant Solid Neoplasm →
- Metastatic Lung Non-Small Cell Carcinoma — all drugs for Metastatic Lung Non-Small Cell Carcinoma →
- Stage IV Lung Non-Small Cell Cancer AJCC v7 — all drugs for Stage IV Lung Non-Small Cell Cancer AJCC v7 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Malignant Solid Neoplasm or Metastatic Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized phase I/II trial studies the side effects and best dose of pembrolizumab when given together with stereotactic body radiation therapy or non-stereotactic wide-field radiation therapy (conventional radiation therapy) and to see how well they work in treating patients with non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab together with radiation therapy may kill more tumor cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Radiotherapy combined with immunotherapy: the dawn of cancer treatment.
Zhang Z, Liu X, Chen D, Yu J. · · 2022 · cited 463× · PMID 35906199 · DOI 10.1038/s41392-022-01102-y -
Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials.
Theelen WSME, Chen D, Verma V, Hobbs BP, et al · · 2021 · cited 404× · PMID 33096027 · DOI 10.1016/s2213-2600(20)30391-x -
Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach?
Bernstein MB, Krishnan S, Hodge JW, Chang JY. · · 2016 · cited 325× · PMID 26951040 · DOI 10.1038/nrclinonc.2016.30 -
Current clinical trials testing the combination of immunotherapy with radiotherapy.
Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7 -
Pembrolizumab with or without radiation therapy for metastatic non-small cell lung cancer: a randomized phase I/II trial.
Welsh J, Menon H, Chen D, Verma V, et al · · 2020 · cited 211× · PMID 33051340 · DOI 10.1136/jitc-2020-001001 -
Immune Checkpoint Inhibitors in Non-Small Cell Lung Cancer: Progress, Challenges, and Prospects.
Tang S, Qin C, Hu H, Liu T, et al · · 2022 · cited 181× · PMID 35159131 · DOI 10.3390/cells11030320 -
Mechanism insights and therapeutic intervention of tumor metastasis: latest developments and perspectives.
Shi X, Wang X, Yao W, Shi D, et al · · 2024 · cited 139× · PMID 39090094 · DOI 10.1038/s41392-024-01885-2 -
SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges.
Chen Y, Gao M, Huang Z, Yu J, et al · · 2020 · cited 125× · PMID 32723363 · DOI 10.1186/s13045-020-00940-z
Verify or expand the search:
- PubMed search for NCT02444741
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02444741 (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 M.D. Anderson Cancer Center
- Last refreshed: 9 October 2025
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/NCT02444741.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing