TABLE 1.
Representative ongoing or completed clinical trials using PD‐1/PD‐L1/CTLA‐4 inhibitors and RT for NSCLC
| ClinicalTrials.gov identifier | Trial Phase | Drug classification | Inventions | Sponsors | Estimated/Actual study completion date | Status |
|---|---|---|---|---|---|---|
| Early‐stage NSCLC | ||||||
| NCT03801902 | 1 | PD‐L1 inhibitors |
Arm I: 13 cycles × durvalumab with ACRT (60 Gy in 15 fractions) Arm II: 13 cycles × durvalumab with standard RT (60 Gy in 30 fractions) |
National Cancer Institute (NCI) | Dec 31, 2021 | Active, not recruiting |
| NCT03383302 | 1/2 | PD‐1 inhibitors | 1 year × nivolumab following SBRT (54 Gy in 3 fractions or 55 Gy in 5 fractions) | Royal Marsden NHS Foundation Trust | Jan 01, 2022 | Recruiting |
| NCT03110978 | 2 | PD‐1 inhibitors |
Arm I: 1‐2 weeks × SBRT Arm II: 1‐3 cycles × nivolumab with 1‐2 weeks × SBRT |
M.D. Anderson Cancer Center | Jun 30, 2022 | Recruiting |
| NCT03148327 | 1/2 | PD‐L1 inhibitors |
Arm I: 5 cycles × durvalumab with SBRT (54Gy, 50Gy or 65Gy in 3, 4 or 10 fractions) Arm II: SBRT (54Gy, 50Gy or 65Gy in 3, 4 or 10 fractions) |
Jonsson Comprehensive Cancer Center | Jun 01, 2023 | Active, not recruiting |
| NCT03924869 | 3 | PD‐1 inhibitors |
Arm 1:17 cycles × pembrolizumab with SBRT (45‐54 Gy in 3‐5 fractions) Arm 2:17 cycles × placebo with SBRT (45‐54 Gy in 3‐5 fractions) |
Merck Sharp & Dohme Corp | Jul 01, 2026 | Recruiting |
| NCT04271384 | 2 | PD‐1 inhibitors |
3 cycles × nivolumab with SAR (54 Gy in 3 fractions or 50 Gy in 5 fractions or 60 Gy in 8 fractions) |
Hospital Israelita Albert Einstein | Jun 29, 2023 | Recruiting |
| NCT03833154 | 3 | PD‐L1 inhibitors |
Arm 1:24 months × durvalumab with SBRT (in 3, 4, 5 or 8 fractions) Arm 2:24 months × placebo with SBRT (in 3, 4, 5 or 8 fractions) |
AstraZeneca | Oct 31, 2025 | Recruiting |
| Locally‐advanced NSCLC | ||||||
| NCT03801902 | 1 | PD‐L1 inhibitors |
Arm I: 13 cycles × durvalumab with ACRT (60 Gy in 15 fractions) Arm II: 13 cycles × durvalumab with standard RT (60 Gy in 30 fractions) |
National Cancer Institute (NCI) | Dec 31, 2021 | Active, not recruiting |
| NCT04013542 | 1 |
PD‐1 and CTLA‐4 inhibitors |
Concurrent therapy:8 cycles × nivolumab and 4 cycles × ipilimumab with 6‐7 weeks × RT Maintenance therapy:8 cycles × nivolumab |
M.D. Anderson Cancer Center | Feb 01, 2022 | Recruiting |
| NCT03818776 | 1 | PD‐L1 inhibitors |
Arm I: 13 cycles × durvalumab with Proton beam therapy RT (60 CGyE in 20 fractions) Arm II: 13 cycles × durvalumab with Proton beam therapy RT (69 CGyE in 23 fractions) |
Case Comprehensive Cancer Center | Nov 01, 2022 | Recruiting |
| NCT04765709 | 2 | PD‐1 inhibitors |
Part 1: Induction with durvalumab and platinum‐based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed) Part 2: Eligible for durvalumab and RT Part 3: Eligible for durvalumab maintenance |
Mario Negri Institute for Pharmacological Research | Jun 01, 2026 | Not yet recruiting |
| NCT03519971 | 3 | PD‐L1 inhibitors |
Arm I: Durvalumab + platinum‐based chemotherapy (cisplatin/etoposide, carboplatin/paclitaxel, pemetrexed/cisplatin, pemetrexed/carboplatin) and RT Arm II: Placebo + platinum‐based chemotherapy (cisplatin/etoposide, carboplatin/paclitaxel, pemetrexed/cisplatin, pemetrexed/carboplatin) and RT |
AstraZeneca | Nov 13, 2023 | Active, not recruiting |
| NCT03523702 | 2 | PD‐1 inhibitors |
PembroRT Cohort: 15 cycles × pembrolizumab with 4 weeks × RT ChemoRT Cohort: Chemotherapy (carboplatin and paclitaxel) with 4‐7 weeks × RT |
Albert Einstein College of Medicine | Sep 01, 2022 | Recruiting |
| NCT04230408 | 2 | PD‐L1 inhibitors |
Induction chemo‐immunotherapy phase: 2 cycles × paclitaxel, carboplatin and durvalumab Concurrent chemo‐immuno‐radiotherapy phase: RT with paclitaxel, carboplatin and durvalumab Consolidation immunotherapy:12 cycles × durvalumab |
Latin American Cooperative Oncology Group | May 01, 2024 | Recruiting |
| NCT03102242 | 2 | PD‐L1 inhibitors |
Induction immunotherapy:4 cycles × atezolizumab Chemoradiotherapy:6 cycles × carboplatin and paclitaxel with RT (60 Gy in 30 fractions) Adjuvant immunotherapy: 1 year × atezolizumab |
Alliance Foundation Trials, LLC | Mar 01, 2020 | Active, not recruiting |
| NCT03237377 | 2 |
PD‐L1 and CTLA‐4 inhibitors |
Arm 1: 3 cycles × durvalumab with RT (45Gy in 25 fractions) Arm 2: 3 cycles × durvalumab and tremelimumab with RT (45Gy in 25 fractions) |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Sep 01, 2021 | Recruiting |
| NCT04597671 | 3 | PD‐L1 inhibitors |
Arm I: Durvalumab with low‐dose PCI (15 Gy in 10 fractions) Arm II: Durvalumab with observation |
Association NVALT Studies | Nov 01, 2027 | Not yet recruiting |
| NCT03774732 | 3 | PD‐1 inhibitors |
Arm 1: Pembrolizumab and chemotherapy (carboplatin/paclitaxel, cisplatin/pemetrexed, carboplatin/pemetrexed) Arm 2: Pembrolizumab and chemotherapy (carboplatin/paclitaxel, cisplatin/pemetrexed, carboplatin/pemetrexed) with 3D‐CRT (18 Gy in 3 fractions) or SBRT |
UNICANCER | May 15, 2023 | Recruiting |
| NCT04577638 | 2 | PD‐1 inhibitors | 3 cycles × nivolumab with IMRT (66 Gy in 24 fractions)+ 6 months × nivolumab maintenance | Center Eugene Marquis | April 1, 2023 | Not yet recruiting |
| Advanced NSCLC | ||||||
| NCT03168464 | 1/2 |
PD‐1 and CTLA‐4 inhibitors |
Ipilimumab and nivolumab with RT (30 Gy in 5 fractions) | Weill Medical College of Cornell University | Dec 30, 2022 | Recruiting |
| NCT03158883 | 1 | PD‐L1 inhibitors | Avelumab with SAR (50 Gy in 5 fractions) | Megan Daly, MD | Jun 01, 2022 | Recruiting |
| NCT03275597 | 1 |
PD‐L1 and CTLA‐4 inhibitors |
Durvalumab and tremelimumab with SBRT (30 ‐ 50 Gy in 5 fractions) | University of Wisconsin, Madison | Oct 01, 2022 | Recruiting |
| NCT03035890 | Not Applicable | PD‐1 or PD‐L1 inhibitors | RT (24‐45 Gy in 3 fractions or 30‐50 Gy in 5fractions) with nivolumab or pembrolizumab or atezolizumab | West Virginia University | Jun 30, 2023 | Active, not recruiting |
| NCT04081688 | 1 | PD‐L1 inhibitors | 18 cycles × atezolizumab and varlilumab with 2 cycles × SBRT | Rutgers, The State University of New Jersey | Jun 30, 2023 | Recruiting |
| NCT03825510 | Not Applicable | PD‐1 inhibitors | Nivolumab or pembrolizumab with SBRT | Crozer‐Keystone Health System | Aug 28, 2021 | Recruiting |
| NCT03915678 | 2 | PD‐L1 inhibitors | Atezolizumab and BDB001 with RT (27‐60 Gy in 3‐5 fractions) | Institut Bergonié | Mar 01, 2025 | Not yet recruiting |
| NCT03774732 | 3 | PD‐1 inhibitors |
Arm 1:Pembrolizumab and chemotherapy (carboplatin/paclitaxel, cisplatin/pemetrexed, carboplatin/pemetrexed) |
UNICANCER | May 15, 2023 | Recruiting |
|
Arm 2:Pembrolizumab and chemotherapy (carboplatin/paclitaxel, cisplatin/pemetrexed, carboplatin/pemetrexed) with 3D‐CRT (18 Gy in 3 fractions) or SBRT |
||||||
| NCT03509584 | 1 |
PD‐1 and CTLA‐4 inhibitors |
Part 1a: Nivolumab with hypofractionated RT (24 Gy in 3 fractions)(bone metatase) Part 1b: Nivolumab and ipilimumab with hypofractionated RT (24 Gy in 3 fractions)(bone metatase) Part 2a: Nivolumab with hypofractionated RT (24 Gy in 3 fractions)(outside the brain) Part 2b: Nivolumab and ipilimumab with hypofractionated RT (24 Gy in 3 fractions)(outside the brain) |
Assistance Publique Hopitaux De Marseille | April 2021 | Not yet recruiting |
| NCT02221739 | 1/2 | CTLA‐4 inhibitors | 3 cycles × ipilimumab with RT (IMRT or 3‐D CRT)(30 Gy in 5 fractions or 28.5 Gy in 3 fractions) | NYU Langone Health | Oct 27, 2015 | Completed |
| NCT03223155 | 1 |
PD‐1 and CTLA‐4 inhibitors |
Sequential Arm: SBRT (in 3‐5 fractions)and nivolumab and ipilimumab Concurrent Arm: Nivolumab and ipilimumab with SBRT (in 3‐5 fractions) |
University of Chicago | Dec 01, 2024 | Recruiting |
| NCT02888743 | 2 |
PD‐L1 and CTLA‐4 inhibitors |
Arm I:4 cycles × tremelimumab and 13 cycles × durvalumab Arm II: 4 cycles × tremelimumab and 13 cycles × durvalumab with High‐dose RT Arm III: 4 cycles × tremelimumab and 13 cycles × durvalumab with Low‐dose RT |
National Cancer Institute (NCI) | Dec 31, 2021 | Active, not recruiting |
| NCT02463994 | 1 | PD‐L1 inhibitors | MPDL3280A + HIGRT | University of Michigan Rogel Cancer Center | Nov 07, 2018 | Completed |
RT, Radiotherapy; ACRT, Accelerated Hypofractionated Radiotherapy; SBRT, Stereotactic Body Radiotherapy; SAR, Stereotactic Ablative Radiotherapy; PCI, Prophylactic Cranial Irradiation; 3D‐CRT, Conformal 3D Radiotherapy; IMRT, Intensity‐Modulated Radiotherapy; HIGRT, Hypofractionated Image‐guided Radiotherapy.