Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00064077 | Uterine Cervical Neoplasms | Duration of Overall Survival (OS) Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | Arm I (Paclitaxel, Cisplatin) | 12.87 months |
| Arm II (Vinorelbine, Cisplatin) | 9.99 months | |||
| Arm III (Gemcitabine, Cisplatin) | 10.28 months | |||
| Arm IV (Topotecan, Cisplatin) | 10.25 months | |||
| NCT00088530 | Lymphoma, Non-Hodgkin | Complete Response (CR) and Complete Response Unconfirmed (CRu) EOT; approximately 6 months | Comparator Group | 5.7 percentage of randomized patients |
| Comparator Group | 7.1 percentage of randomized patients | |||
| Experimental Group | 20.0 percentage of randomized patients | |||
| Experimental Group | 24.3 percentage of randomized patients | |||
| NCT00148798 FLEX | Carcinoma, Non-Small-Cell Lung | Overall Survival Time (OS) Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Cetuximab Plus Chemotherapy | 11.3 months |
| Chemotherapy Alone | 10.1 months | |||
| NCT00169104 | Breast Neoplasms | Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Trastuzumab With Either G-CSF or a Saline Placebo Against a Her-2 Overexpressing Target in Vitro Baseline and 12 days | G-CSF Arm | 1.47 percentage of specific lysis (±0.97 Standard Deviation) |
| Placebo Arm | 1.67 percentage of specific lysis (±2.34 Standard Deviation) | |||
| NCT00302003 | Hodgkin Disease | Event Free Survival (EFS) At 60 months | Group 1 | 0.79 Probability of survival |
| NCT00302003 | Hodgkin Disease | Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). At 60 months | Group 1 | 0.49 Probability of survival |
| NCT00302003 | Hodgkin Disease | Intensive Therapy Free Survival (ITFS). At 60 months | Group 1 | 0.89 Probability of survival |
| NCT00324805 | Carcinoma, Non-Small-Cell Lung | Overall Survival From registration to death, up to 10 years | Arm I (Chemotherapy) | NA months |
| Arm II (Chemotherapy, Bevacizumab) | 85.8 months | |||
| NCT00499109 | Carcinoma, Non-Small-Cell Lung | Progression Free Survival (PFS) 6 months | C. Standard of Care Control Arm | 56.5 estimated percentage of participants |
| E. Dual Agent Chemotherapy | 52 estimated percentage of participants | |||
| NCT00686959 PROCLAIM | Carcinoma, Non-Small-Cell Lung | Overall Survival Baseline to Date of Death from Any Cause (Up to 71.4 Months) | Arm A: Pemetrexed + Cisplatin and TRT | 26.81 months |
| Arm B: Etoposide + Cisplatin and TRT | 24.97 months | |||
| NCT01007942 BOLERO-3 | Breast Neoplasms | Progressive-free Survival (PFS) Per Investigator Assessment Every 6 weeks until disease progression or death which ever occurred first up to about 41 months | Everolimus + Vinorelbine + Trastuzumab | 7.00 months |
| Placebo + Vinorelbine + Trastuzumab | 5.78 months | |||
| NCT01026220 | Hodgkin Disease | Safety Analysis and Monitoring of Toxic Death Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months). | Group 1 | 0 participants |
| NCT01026220 | Hodgkin Disease | Second-event-free Survival At 4 years from enrollment | Group 1 | 0.91 Probability of survival |
| Group 2 | 0.94 Probability of survival | |||
| Group 3 | 0.88 Probability of survival | |||
| NCT01125566 | Breast Neoplasms | Progression-free Survival (PFS) From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months | Afatinib + Vinorelbine (AV) | 5.49 Months |
| Trastuzumab + Vinorelbine (TV) | 5.55 Months | |||
| NCT01454934 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) Randomization (Day 1) until date of death from any cause, or 37 months | Arm A: Eribulin Mesylate | 9.5 months |
| Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed | 9.5 months | |||
| NCT02352948 ARCTIC | — | Overall Survival (OS) From randomization (Day 1) until death due to any cause, approximately 36 months | Sub-study A: Durvalumab | 11.7 months |
| Sub-study A: SoC | 6.8 months | |||
| Sub-study B: Durvalumab+Tremelimumab | 11.5 months | |||
| Sub-study B: SoC | 8.7 months | |||
| NCT02352948 ARCTIC | — | Progression-Free Survival (PFS) Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years. | Sub-study A: Durvalumab | 3.8 months |
| Sub-study A: SoC | 2.2 months | |||
| Sub-study B: Durvalumab+Tremelimumab | 3.5 months | |||
| Sub-study B: SoC | 3.5 months | |||
| NCT02486718 | Carcinoma, Non-Small-Cell Lung | DFS in All Randomized Stage II-IIIA Population Up to 95 months | Atezolizumab | 57.4 months |
| Best Supportive Care (BSC) | 40.8 months | |||
| NCT02486718 | Carcinoma, Non-Small-Cell Lung | DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population Up to 95 months | Atezolizumab | 68.5 months |
| Best Supportive Care (BSC) | 37.3 months | |||
| NCT02486718 | Carcinoma, Non-Small-Cell Lung | Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population Up to 95 months | Atezolizumab | 65.6 months |
| Best Supportive Care (BSC) | 47.8 months | |||
| NCT02555657 | Triple Negative Breast Neoplasms | Overall Survival in All Participants Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019) | Chemotherapy | 10.8 Months |
| Pembrolizumab | 9.9 Months | |||
| NCT02555657 | Triple Negative Breast Neoplasms | Overall Survival in Participants With PD-L1 CPS ≥1 Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019) | Chemotherapy | 10.2 Months |
| Pembrolizumab | 10.7 Months | |||
| NCT02555657 | Triple Negative Breast Neoplasms | Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10 Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019) | Chemotherapy | 11.6 Months |
| Pembrolizumab | 12.7 Months | |||
| NCT02567435 | Rhabdomyosarcoma | Event-free Survival (EFS) Up to 3 years from study entry | Regimen A (VAC/VI) | 64.80 Percentage of participants |
| Regimen B (VAC/VI/Temsirolimus) | 66.80 Percentage of participants | |||
| NCT02574455 ASCENT | Breast Neoplasms | Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Sacituzumab Govitecan | 5.6 months |
| Treatment of Physician's Choice (TPC) | 1.7 months | |||
| NCT02915744 ATTAIN | Breast Neoplasms | Overall Survival (OS) of Patients Within 3 years from study start | NKTR-102 | 7.8 months |
| Treatment of Physician's Choice (TPC) | 7.5 months | |||
| NCT02991482 PROMISE-meso | — | Progression Free Survival (PFS) as Assessed by Independent Radiological Review Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | Pembrolizumab Arm | 2.5 months |
| Standard Chemotherapy Arm | 3.4 months | |||
| NCT02998528 CheckMate 816 | Carcinoma, Non-Small-Cell Lung | Event-Free Survival (EFS) From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) | Arm B: Platinum Doublet Chemo | 21.06 Months |
| Arm B: Platinum Doublet Chemo | 20.80 Months | |||
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 59.60 Months | |||
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 31.57 Months | |||
| NCT02998528 CheckMate 816 | Carcinoma, Non-Small-Cell Lung | Pathologic Complete Response (pCR) Rate From randomization up to a median of 30 months after randomization. | Arm B: Platinum Doublet Chemo | 4 Participants |
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 43 Participants | |||
| NCT03191786 IPSOS | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) From randomization up to death from any cause (up to approximately 55 months) | Atezolizumab | 10.3 Months |
| Single Agent Chemotherapy (Vinorelbine or Gemcitabine) | 9.2 Months | |||
| NCT03456076 | Carcinoma, Non-Small-Cell Lung | Disease-free Survival (DFS), as Assessed by the Investigator Approximately 58 months | Alectinib | NA months |
| Alectinib | NA months | |||
| Platinum-Based Chemotherapy | 41.3 months | |||
| Platinum-Based Chemotherapy | 44.4 months | |||
| NCT03901339 TROPiCS-02 | Breast Neoplasms | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Up to 42.8 months | Sacituzumab Govitecan | 5.5 months |
| Treatment of Physician's Choice (TPC) | 4.0 months | |||
| NCT04697628 innovaTV 301 | Uterine Cervical Neoplasms | Overall Survival From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months) | Chemotherapy | 9.5 Months |
| Tisotumab Vedotin | 11.5 Months | |||
| NCT05104866 | Breast Neoplasms | Overall Survival From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. | Dato-DXd | 18.6 Months |
| Investigator's Choice of Chemotherapy (ICC) | 18.3 Months | |||
| NCT05104866 | Breast Neoplasms | Progression-Free Survival On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months | Dato-DXd | 6.9 Months |
| Investigator's Choice of Chemotherapy (ICC) | 4.9 Months |