Table 1 Ongoing Phase 3 neoadjuvant chemoimmunotherapy trials in solid tumors
From: Increasing cure rates of solid tumors by immune checkpoint inhibitors
Organ system | Clinical trial | Cancer type | Phase | Participant numbers | Trial design | Estimated study completion (year) | Primary endpoint(s) |
|---|---|---|---|---|---|---|---|
Lung | NCT02998528 (CheckMate 816) | Early Stage NSCLC | III | 350 | Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy VS Platinum Doublet Chemotherapy | 2028 | Event-Free Survival (EFS); Pathological Complete Response (pCR) |
| Â | NCT03456063 (IMpower030) | Resectable Stage II, IIIA, or Select IIIB NSCLC | III | 453 | Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy | 2026 | Event Free Survival |
| Â | NCT04025879 (CA209-77Â T) | Surgically Removable Early Stage NSCLC | III | 452 | Neoadjuvant Chemotherapy Plus Nivolumab VS Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo | 2024 | Event-Free Survival |
|  | NCT03425643 (KEYNOTE-671) | Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) NSCLC | III | 786 | Platinum Doublet Chemotherapy ± Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy | 2026 | Event Free Survival; Overall Survival |
| Â | NCT03800134 (AEGEAN) | Resectable Stages II and III NSCLC | III | 800 | Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients | 2024 | Event-Free Survival; Pathological Complete Response |
| Â | NCT05157776 | Resectable Locally Advanced NSCLC Harboring no Driver Mutations | III | 72 | Neoadjuvant Sintilimab and Platinum-based Chemotherapy | 2023 | Pathologically complete response rate |
GI tract | NCT04807673 | Esophageal Squamous Cell Carcinoma | III | 342 | Pembrolizumab Plus Paclitaxel and Cisplatin VS Neoadjuvant Chemoradiotherapy Followed by Surgery | 2028 | Event Free Survival |
| Â | NCT04848753 | Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma | III | 500 | Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy | 2026 | Event Free Survival |
| Â | NCT04973306 | Esophageal Squamous Cell Carcinoma | II-III | 176 | Anti-PD-1 antibody (Tislelizumab, BeiGene) combined with neoadjuvant chemoradiotherapy VS neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy | 2027 | Major pathologic response; OS |
|  | NCT04304209 | Colorectal Cancer | II-III | 195 | Neoadjuvant Sintilimab ± Chemoradiotherapy | 2026 | Pathologic complete response rate |
| Â | NCT02743494 (CheckMate 577) | Resected stage II-III esophageal or GE junction cancer | III | 794 | Neoadjuvant chemoRT followed by complete resection, with residual disease adjuvant Nivolumab VS placebo | 2025 | Disease Free Survival |
|  | NCT05270824 | Advance Gastric Adenocarcinoma | III | 120 | Radical surgery after neoadjuvant immunotherapy (albumin Paclitaxel + Seggio + PD-1 inhibitor) VS adical surgery after neoadjuvant chemotherapy (albumin Paclitaxel + Seggio) | 2027 | CD8 + tumor-infiltrating lymphocytes in tumor tissue |
| Â | NCT04882241 | Gastric Cancer | III | 120 | Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) VS Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment | 2025 | Event-Free Survival (EFS); Pathological Complete Response (pCR);Overall Survival |
GU | NCT03732677 | Muscle Invasive Bladder Cancer | III | 988 | Durvalumab in Combination With Gemcitabine + Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone | 2026 | Event-Free Survival; Pathological Complete Response |
| Â | NCT04700124 | Muscle Invasive Bladder Cancer | III | 784 | Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) VS Neoadjuvant Gemcitabine and Cisplatin | 2026 | Event-Free Survival; Pathological Complete Response |
| Â | NCT04209114 | Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible | III | 540 | Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, VS Nivolumab Alone Versus Standard of Care | 2024 | Event-Free Survival; Pathological Complete Response |
|  | NCT04209114 | MIBC ineligible for cisplatin | III | 540 | Neoadjuvant and Adjuvant Nivolumab + Bempeg/NKTR-214, VS Nivolumab Alone vs Standard of Care w radical cystectomy | 2024 | Event-Free Survival; Pathological Complete Response |
|  | NCT04700124 (KEYNOTE-B15) | Cisplatin-eligible Muscle Invasive Bladder Cancer | III | 784 | Perioperative Enfortumab Vedotin + Pembrolizumab 1 yr VS Neoadjuvant Gemcitabine and Cisplatin | 2026 | Event-Free Survival; Pathological Complete Response |
GYN | NCT03038100 | Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | III | 1301 | Paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab VS paclitaxel, carboplatin and placebo | 2023 | PFS, OS |
Head and Neck | NCT03700905 | Head and Neck Cancer | III | 276 | Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy VS Standard Follow-up | 2024 | Disease Free Survival |
| Â | NCT03765918 (Keynote 689) | Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma | III | 704 | Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy | 2026 | Major Pathological Response (mPR);Event-free Survival |
| Â | NCT05125055 | Oral Squamous Cell Carcinoma | II-III | 80 | Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin VS Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients | 2025 | Major pathologic response |
| Â | NCT04557020 | High-risk Nasopharyngeal Carcinoma | III | 200 | Toripalimab with neoadjuvant cis Platinum and gemcitabine VS Standard cis Platinum and gemcitabine | 2024 | PFS |
Skin | NCT04949113 | Macroscopic Stage III Melanoma | III | 420 | Neoadjuvant Ipilimumab Plus Nivolumab VS Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma | 2027 | Event Free Survival |
|  | NCT04949113 (NADINA) | Stage III Melanoma | III | 420 | Neoadjuvant Ipilimumab + Nivolumab (adjuvant Nivo in residual disease or dabrafenib/tremetinib in BRAF V600 mut) VS Standard Adjuvant Nivolumab 1 yr | 2027 | Event Free Survival |
Breast | NCT03725059 (KEYNOTE-756) | Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER + /HER2-) Breast Cancer | III | 1240 | Pembrolizumab VS Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy | 2031 | Event-Free Survival; Pathological Complete Response |
| Â | NCT03036488 | Triple Negative Breast Neoplasms | III | 1174 | Pembrolizumab Plus Chemotherapy VS Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy | 2025 | Event-Free Survival; Pathological Complete Response |
| Â | NCT04613674 | Triple Negative Breast Cancer | III | 581 | Camrelizumab Plus Chemotherapy VS Placebo Plus Chemotherapy as Neoadjuvant Therapy i | 2023 | Pathological complete response rate |
| Â | NCT02620280 (NeoTRIPaPDL1) | TNBC | III | 278 | Neoadjuvant Atezolizumab or placebo with Carbo/abraxane, surgery followed by adjuvant chemotherapy | 2022 | Event Free Survival |
|  | NCT03726879 (IMpassion050) | Early Her2 + Breast Cancer | III | 454 | Neoadjuvant Atezolizumab or Placebo wtih Neoadjuvant ddAC Followed By THP, adjuvant Atezo 1 yr VS placebo with Her2 HP/TDM1 | 2023 | Pathological Complete Response |
|  | NCT03595592 (APTneo) | Her2 + breast cancer | III | 650 | Neoadjuvant chemotherapy VS Atezolizumab + AC-TCHP VS Atezolizumab + TCHP, surgery followed by adjuvant Atezo + HP | 2026 | Event Free Survival |
|  | NCT04109066 (Checkmate 7FL) | High-risk, ER + , HER2-Early Breast Cancer | III | 1200 | Nivolumab VS Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy | 2032 | Pathological Complete Response, Event Free Survival |
|  | NCT03281954 | TNBC | III | 1520 | Neoadjuvant Chemotherapy With Atezolizumab or Placebo Followed by Adjuvant Atezolizumab or Placebo | 2024 | Pathological Complete Response, Event Free Survival |