Table 1. Current ongoing trials involving the use of radiotherapy and immune checkpoint inhibitors in stage III NSCLCa.
| NCT number | Phase | Title | Enrollment | Treatment arms | Primary end points | Estimated study completion date |
|---|---|---|---|---|---|---|
| NCT04013542 | I | Ipilimumab and nivolumab in combination with radiation therapy in treating patients with stage II–III NSCLC | 11 | RT given concurrently with Ipilimumab plus Nivolumab | Toxicity | February 1, 2022 |
| NCT03801902 | I | Accelerated hypofractionated or conventionally fractionated radiotherapy and durvalumab in treating patients with stage II–III NSCLC | 24 | RT (60 Gy/15 fx) given following durvalumab; RT (60 Gy/30 fx) given following durvalumab | Toxicity | July 28, 2020 |
| NCT02621398 | I | Pembrolizumab, paclitaxel, carboplatin, and radiation therapy in treating patients with stage II–IIIB NSCLC | 30 | Pembrolizumab given concurrently with CCRT | MTD, DLT | December 2021 |
| NCT03663166 | I/II | Radiation and chemotherapy with ipilimumab followed by nivolumab for patients with stage III unresectable NSCLC | 50 | CCRT (60 Gy/30 fx) given concurrently with ipilimumab; CCRT (60 Gy/30 fx) followed by nivolumab | Toxicity, PFS | March 1, 2027 |
| NCT03871153 | II | Chemoradiation plus durvalumab followed by surgery followed by adjuvant durvalumab in patients with surgically resectable stage III (N2) NSCLC | 25 | CCRT (45–61.2 Gy/25–34 fx) given concurrently with durvalumab followed by surgery and adjuvant durvalumab | Pathologic CR | April 2022 |
| NCT03589547 | II | Durvalumab and consolidation SBRT following chemoradiation for locally advanced Stage III NSCLC | 25 | SBRT (20 Gy/2–3 fx) given to primary tumor only concurrently with durvalumab following CCRT | Toxicity, PFS | October 2025 |
| NCT03237377 | II | Neoadjuvant immunoradiation for resectable NSCLC | 32 | Durvalumab concurrently with radiation (45 Gy/25 fx); Durvalumab and tremelimumab concurrently with radiation (45 Gy/25 fx) | Toxicity, feasibility | September 2021 |
| NCT03217071 | II | Pembrolizumab with and without radiotherapy for NSCLC | 40 | SBRT (12 Gy/1 fx) given to 50% of primary tumor following pembrolizumab Pembrolizumab alone | Immunomonitoring | September 1, 2021 |
| NCT04230408 | II | Intensified chemo-immuno-radiotherapy with durvalumab for stage III NSCLCs (PACIFIC BRAZIL) | 48 | Durvalumab as induction, concurrent and consolidation therapy for CCRT | PFS | April 2024 |
| NCT04003246 | II | Phase II concurrent durvalumab and radiotherapy for stage iii non-small cell lung cancer | 50 | RT given concurrently with durvalumab and followed by durvalumab | PFS | August 2026 |
| NCT03999710 | II | Determining whether durvalumab in combination with radiation therapy can prevent the progression of NSCLC | 53 | RT given concurrently with durvaluamb | PFS | July 2021 |
| NCT03523702 | II | The selective personalized radio-immunotherapy for locally advanced NSCLC trial (SPRINT) | 63 | CCRT for patients with PD-L1 expression <50%; Pembrolizumab as induction and consolidation therapy for CCRT in patients with PD-L1 expression >50% | PFS | July 2021 |
| NCT04245514 | II | Multimodality treatment in stage III NSCLC | 90 | RT (20×2 Gy) given concurrently with durvalumab; RT (5×5 Gy) given concurrently with durvalumab; RT (3×8 Gy) given concurrently with durvalumab | EFS | March 2025 |
| NCT03285321 | II | Unresectable stage IIIA/IIIB NSCLC | 108 | Nivolumab following CCRT; Nivolumab plus Ipilimumab following CCRT | PFS | September 30, 2022 |
| NCT03693300 | II | A Study to determine safety of durvalumab after sequential chemo radiation in patients with unresectable stage III NSCLC |
150 | Durvalumab given as consolidation therapy following SCRT | Toxicity | February 21, 2023 |
| NCT03631784 | II | A trial of pembrolizumab in combination with chemotherapy and radiotherapy in stage III NSCLC (KEYNOTE-799, MK-3475-799). (KEYNOTE-799) |
216 | CCRT (paclitaxel plus carboplatin) given concurrently with pembrolizumab; CCRT (pemetrexed plus cisplatin) given concurrently with pembrolizumab | Toxicity, ORR | March 14, 2022 |
| NCT04085250 | II | Study of nivolumab for NSCLC (stage III) following neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy | 264 | Nivolumab used as neoadjuvant and consolidation therapy for CCRT; Nivolumab used as neoadjuvant therapy for CCRT | PFS | November 27, 2023 |
| NCT03706690 | III | A study of durvalumab as consolidation therapy in NSCLC patients (PACIFIC-5) | 360 | Durvalumab as consolidation therapy for CCRT; Placebo as consolidation therapy for CCRT | PFS | January 31, 2025 |
| NCT04092283 | III | Testing the addition of an antibody to standard chemoradiation followed by the antibody for one year to standard chemoradiation followed by one year of the antibody in patients with unresectable stage III NSCLC | 660 | CCRT given concurrently with durvalumab and followed by durvalumab; CCRT followed by durvalumab as consolidation therapy | OS | October 31, 2028 |
| NCT04026412 | III | A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgery (CheckMate73L) | 1,400 | CCRT concurrently given with nivolumab followed by nivolumab plus ipilimumab CCRT concurrently given with nivolumab followed by nivolumab; CCRT followed by durvalumab |
PFS, OS | November 30, 2024 |
a, only studies focusing exclusively on a NSCLC patient population are represented in this table. NSCLC, non-small cell lung cancer; CR, complete response; CCRT, concurrent chemoradiotherapy; DCR, disease control rate; DLT, dose-limiting toxicity; EFS, event free survival; fraction(s); Gy, Gray; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression free survival; RT, radiotherapy; SBRT, stereotactic body radiotherapy; SCRT, sequential chemoradiotherapy.