Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma
TerminatedPhase 3Results postedLast updated 19 February 2025
What this trial tests
Phase 3 trial testing Carboplatin in Pleural Biphasic Mesothelioma in 16 participants. Terminated before completion.
Adults 18 to 80, any sex, with Pleural Biphasic Mesothelioma or Pleural Epithelioid Mesothelioma. 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.
Overall Survival (OS)Primary· Randomization to the date of death or last follow-up. Maximum follow-up time from randomization was 25 months.
Overall survival was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive at time of study termination is reported.
Group
Value
95% CI
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
5
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
4
Local-failure-free Survival (LFFS)Secondary· From randomization to local failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
Local failure is defined as local enlargement (LE) or local failure (LF) tumor response, marginal failure (MF), or death. LFFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without failure at time of study termination is reported, and no statistical testing was done.
LE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the tr
Group
Value
95% CI
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
3
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
3
Distant-metastases-free Survival (DMFS)Secondary· From randomization to distant failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
Distant failure (DF) is defined as the appearance of cancer deposits characteristic of metastatic dissemination from mesothelioma. DMFS was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without failure at time of study termination is reported, and no statistical testing was done.
Group
Value
95% CI
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
5
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
2
Progression-free Survival (PFS)Secondary· From randomization to first progression, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
Progression is defined as LE, LF, MF, DF, or death. PFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when ≥ 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without progression at study termination is reported, and no statistical testing was done.
LE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the treatment start; based on CT scan.
LF: Progression of pleural tumor thickness or ap
Group
Value
95% CI
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
3
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
2
Number of Patients With Grade 3 or Higher Treatment-related Adverse Event After RandomizationSecondary· From randomization to death or last follow-up. Maximum follow-up time was 25 months.
Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.
Group
Value
95% CI
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
0
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pre-randomization
Serious: 0/13 (0%)
Deaths: 0/16
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
Serious: 0/4 (0%)
Deaths: 0/5
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
This trial studies how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, 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 targeted radiation therapy in addition to surgery and chemotherapy may work better than surgery and chemotherapy alone for the treatment of malignant pleural mesothelioma.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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 Pleural Biphasic Mesothelioma
Currently open trials in the same condition.
NCT05647265 — Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
· Phase 2
· recruiting
NCT02399371 — Pembrolizumab in Treating Patients With Malignant Mesothelioma
· Phase 2
· active not recruiting
Other NRG Oncology trials
Trials by the same sponsor.
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive
· Phase 3
· not yet recruiting
NCT07452458 — Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, ID
· Phase 3
· not yet recruiting
NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-
· Phase 3
· recruiting
NCT07097142 — Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemothera
· Phase 3
· recruiting
NCT06958328 — Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
· Phase 3
· recruiting
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 NRG Oncology
Last refreshed: 19 February 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/NCT04158141.