Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
CompletedPhase 2Results postedLast updated 25 November 2025
What this trial tests
Phase 2 trial testing Carboplatin in Recurrent Lung Non-Small Cell Carcinoma in 20 participants. Completed in 23 December 2023.
18 and older, any sex, with Recurrent Lung Non-Small Cell Carcinoma or Stage II Lung Cancer AJCC v8. 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.
Proportion of Participants With Progression Free Survival (PFS)Primary· From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value \< 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value \< 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
0.6
0.362 – 0.995
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
0.429
0.182 – 1.00
Overall Survival (OS)Secondary· From randomization to death due to any cause, assessed up to 5 years
Will be modeled using Cox models. Kaplan-Meier estimates and curves by dose level will also be generated. OS will again be analyzed as exploratory analysis after 50 deaths per primary pairwise comparison have occurred or after all patients have completed follow-up (whichever occurs first).
Alive
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
4
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
2
Dead
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
6
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
5
Number of Participants With Adverse EventsSecondary· Up to 5 years
Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are graded on a scale of 0-5 with 5 being worst. The number of participants with Grade 2 or higher adverse events will be reported.
AE Grade 2+
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
9
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
6
AE Grade 3+
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
6
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
5
Proportion of Participants With Local-regional FailureSecondary· Up to 5 years
Defined as the proportion of participants with documentation of local recurrence. The cumulative incidence of local failure will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk).
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
0.2
0.057 – 0.51
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
0.14
0.026 – 0.51
Proportion of Participants With Distant MetastasisSecondary· Up to 5 years
Defined as the proportion of participants with documentation of distant metastasis. The cumulative incidence of distant metastasis will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk).
Group
Value
95% CI
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
0.1
0.018 – 0.40
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
0.29
0.08 – 0.64
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
Serious: 5/10 (50%)
Deaths: 6/10
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
This randomized phase II trial studies how well platinum doublet chemotherapy and proton beam radiation therapy work in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as carboplatin, paclitaxel, etoposide, cisplatin, and pemetrexed 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. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Giving platinum doublet chemotherapy and proton beam radiation therapy may work better in treating patients with non-small cell lung cancer.
Publications & conference data
3 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 Recurrent Lung Non-Small Cell Carcinoma
Currently open trials in the same condition.
NCT06616584 — Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had
· Phase 2, PHASE3
· recruiting
NCT06616623 — Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
· Phase 1
· recruiting
NCT06031688 — Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung
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· recruiting
NCT05642572 — Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A L
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· recruiting
NCT05570825 — SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer
· Phase 2
· recruiting
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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 Mayo Clinic
Last refreshed: 25 November 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/NCT03132532.