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 |
|---|---|---|---|---|
| NCT00096265 | Carcinoma, Non-Small-Cell Lung | Overall Survival From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months. | Erlotinib + WBRT + SRS | 6.1 months |
| Temozolomide + WBRT + SRS | 6.3 months | |||
| WBRT + SRS | 13.4 months | |||
| NCT00130728 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) Among All Randomized Patients From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) | Erlotinib HCl + Bevacizumab | 9.3 months |
| Erlotinib HCl + Placebo | 9.2 months | |||
| NCT00153803 | Carcinoma, Non-Small-Cell Lung | Progression Free Survival 5 years | Placebo | 8.1 Months |
| Tarceva | 7.4 Months | |||
| NCT00257608 | Carcinoma, Non-Small-Cell Lung | Progression-free Survival (PFS) Approximately 3 years | Bevacizumab + Erlotinib | 4.8 months |
| Bevacizumab + Placebo | 3.7 months | |||
| NCT00364351 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed. | Erlotinib | 8.9 Weeks |
| Vandetanib | 11.3 Weeks | |||
| NCT00373425 RADIANT | Carcinoma, Non-Small-Cell Lung | Disease Free Survival (DFS) Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months). | Erlotinib | 55.0 months |
| Erlotinib | 55.0 months | |||
| Erlotinib | 50.5 months | |||
| Erlotinib | 50.5 months | |||
| Placebo | 56.2 months | |||
| Placebo | 56.2 months | |||
| Placebo | 48.2 months | |||
| Placebo | 48.2 months | |||
| NCT00402779 | Mouth Neoplasms | Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group. 3 years | Erlotinib | 55 Participants |
| Placebo | 18 Participants | |||
| NCT00412217 | Head and Neck Neoplasms | Number of Participants With Disease Progression From inclusion in the study until disease progression (maximum up to 3 years overall) | Erlotinib | 15 participants |
| Placebo | 11 participants | |||
| NCT00412217 | Head and Neck Neoplasms | Time to Progression (TTP) From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall) | Erlotinib | NA months |
| Placebo | NA months | |||
| NCT00446225 EURTAC | Carcinoma, Non-Small-Cell Lung | Progression Free-survival From the date of randomization to the date of last follow up, assessed up to 24 months | A: Erlotinib Group | 9.4 months |
| B: Standard Chemotherapy Group | 5.2 months | |||
| NCT00448240 | Head and Neck Neoplasms | Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy Evaluated at 6-week intervals, up to an average of 18 weeks. | Erlotinib | 2 Participants |
| Erlotinib | 1 Participants | |||
| Erlotinib | 3 Participants | |||
| NCT00457392 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) Baseline to death or 28 days after last dose for the last participant | Erlotinib | 8.5 Months |
| Sunitinib + Erlotinib | 9.0 Months | |||
| NCT00556322 | Carcinoma, Non-Small-Cell Lung | Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010) Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months | Comparator | 5.5 months |
| Erlotinib | 5.3 months | |||
| NCT00556322 | Carcinoma, Non-Small-Cell Lung | Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010) Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months | Comparator | 81.0 percentage of participants |
| Erlotinib | 77.8 percentage of participants | |||
| NCT00556322 | Carcinoma, Non-Small-Cell Lung | Probable Percentage of Participants Remaining Alive at 1 Year 1 Year | Comparator | 24.0 percentage of participants |
| Erlotinib | 26.0 percentage of participants | |||
| NCT00556712 | Carcinoma, Non-Small-Cell Lung | Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Erlotinib, 150 mg/Day | 79.5 percentage of participants |
| Placebo | 89.4 percentage of participants | |||
| NCT00556712 | Carcinoma, Non-Small-Cell Lung | Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Erlotinib, 150 mg/Day | 79.9 percentage of participants |
| Placebo | 89.5 percentage of participants | |||
| NCT00556712 | Carcinoma, Non-Small-Cell Lung | PFS in All Participants (Data Cutoff 17 May 2008) Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Erlotinib, 150 mg/Day | 12.3 weeks |
| Placebo | 11.1 weeks | |||
| NCT00556712 | Carcinoma, Non-Small-Cell Lung | PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Erlotinib, 150 mg/Day | 12.3 weeks |
| Placebo | 11.1 weeks | |||
| NCT00556712 | Carcinoma, Non-Small-Cell Lung | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) 6 months | Erlotinib, 150 mg/Day | 27.0 percentage of participants |
| Placebo | 16.0 percentage of participants | |||
| NCT00556712 | Carcinoma, Non-Small-Cell Lung | Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) 6 months | Erlotinib, 150 mg/Day | 25.0 percentage of participants |
| Placebo | 15.0 percentage of participants | |||
| NCT00673049 NSCLC | Carcinoma, Non-Small-Cell Lung | Overall Survival Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months | Erlotinib | 6.2 months |
| Figitumumab + Erlotinib | 5.7 months | |||
| NCT00718315 | Carcinoma, Non-Small-Cell Lung | Percentage of Participants Who Develop Skin Rash 30 Days | Fisiogel | 60.0 percentage of participants |
| Stiemicyn | 69.2 percentage of participants | |||
| Verutex | 73.1 percentage of participants | |||
| NCT00718315 | Carcinoma, Non-Small-Cell Lung | Percentage of Participants With Skin Rash Stratified by Severity Grade 30 Days | Fisiogel | 29.8 percentage of participants |
| Fisiogel | 0 percentage of participants | |||
| Fisiogel | 0 percentage of participants | |||
| Fisiogel | 0 percentage of participants | |||
| Fisiogel | 49.1 percentage of participants | |||
| Fisiogel | 21.1 percentage of participants | |||
| Stiemicyn | 56.7 percentage of participants | |||
| Stiemicyn | 0 percentage of participants | |||
| Stiemicyn | 25.0 percentage of participants | |||
| Stiemicyn | 0 percentage of participants | |||
| Stiemicyn | 0 percentage of participants | |||
| Stiemicyn | 18.3 percentage of participants | |||
| Verutex | 43.3 percentage of participants | |||
| Verutex | 35.0 percentage of participants | |||
| Verutex | 3.3 percentage of participants | |||
| Verutex | 18.3 percentage of participants | |||
| Verutex | 0 percentage of participants | |||
| Verutex | 0 percentage of participants | |||
| NCT00738881 MARVEL | Carcinoma, Non-Small-Cell Lung | Progression-free Survival (PFS) Time from randomization to the first date of documented disease progression or death, assessed up to 5 years | Arm I | 2 months |
| Arm II | 3.1 months | |||
| NCT00883779 | — | Median Progression Free Survival (PFS) Time Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) | Erlotinib | 7.6 months |
| Placebo | 6.0 months | |||
| NCT00901901 SEARCH | Carcinoma, Hepatocellular | Overall Survival From randomization of the first patient until 34 months or date of death of any cause whichever came first | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 289 Days |
| Sorafenib (Nexavar, BAY43-9006) + Placebo | 259 Days | |||
| NCT01013649 | Pancreatic Intraductal Neoplasms | Overall Survival (Percentage of Participants Alive) [Phase II] From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. | Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 29.9 months |
| Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 28.1 months | |||
| NCT01013649 | Pancreatic Intraductal Neoplasms | Overall Survival (Percentage of Participants Alive) [Phase III] From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization. | Arm III (Chemotherapy) | 31.1 months |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 27.3 months | |||
| NCT01183858 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) | Erlotinib 150 mg | 6.86 weeks |
| Erlotinib 300 mg | 7.00 weeks | |||
| NCT01183858 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) at the End of Study Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) | Erlotinib 150 mg | 6.86 weeks |
| Erlotinib 300 mg | 7.00 weeks | |||
| NCT01244191 | Carcinoma, Non-Small-Cell Lung | Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer Date of randomization up to date of death, up to approximately 1 year 11 months postdose | Placebo and Erlotinib | 7.8 months |
| Tivantinib and Erlotinib | 8.5 months | |||
| NCT01328951 | — | Overall Survival (OS) as Median Time to Event During the Overall Study Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) | Early Erlotinib | 9.72 months |
| Late Erlotinib | 9.46 months | |||
| NCT01328951 | — | Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study At 1 year | Early Erlotinib | 42.15 percentage of participants |
| Late Erlotinib | 41.75 percentage of participants | |||
| NCT01328951 | — | Percentage of Participants Who Died During the Overall Study Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) | Early Erlotinib | 75.2 percentage of participants |
| Late Erlotinib | 73.2 percentage of participants | |||
| NCT01342965 | Carcinoma, Non-Small-Cell Lung | Investigator-assessed Duration of Progression-free Survival Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months) | Chemotherapy | 5.5 Months |
| Erlotinib | 11.0 Months | |||
| NCT01351415 | — | Overall Survival (OS) Up to data cut-off date 24 June 2016 (approximately 5 years) | Bevacizumab + Standard of Care | 11.86 Months |
| Standard of Care | 10.22 Months | |||
| NCT01360554 ARCHER 1009 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) | 2.6 Months |
| Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | 2.5 Months | |||
| NCT01360554 ARCHER 1009 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) Per Independent Radiologic Review. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) | 2.6 Months |
| Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | 2.5 Months | |||
| NCT01523587 | Carcinoma, Non-Small-Cell Lung | Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | Afatinib | 2.63 Months |
| Erlotinib | 1.94 Months | |||
| NCT01652469 EMPHASIS | Carcinoma, Non-Small-Cell Lung | Progression-free Survival The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months. | A: Erlotinib | 1.6 months |
| B: Docetaxel | 3.0 months | |||
| NCT01667562 ESSENCE | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) | Erlotinib | 9.574 months |
| NCT02134015 HER3-Lung | Carcinoma, Non-Small-Cell Lung | Part A: Progression Free Survival (PFS) in Heregulin-high Participants by trial termination (at 20 months) | Patritumab + Erlotinib | 1.9 months |
| Placebo + Erlotinib | 2.7 months | |||
| NCT02134015 HER3-Lung | Carcinoma, Non-Small-Cell Lung | Part A: Progression Free Survival (PFS) in Heregulin-low Participants by trial termination (at 20 months) | Patritumab + Erlotinib | 1.5 months |
| Placebo + Erlotinib | 2.8 months | |||
| NCT02152631 JUNIPER | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) From Randomization Date to Date of Death from Any Cause (Up to 32 Months) | Abemaciclib | 7.4 months |
| Erlotinib | 7.8 months | |||
| NCT02186301 EGFR | Carcinoma, Non-Small-Cell Lung | Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS) Cycle 1 Day 1 to End of Treatment, up to approximately 35 months | Erlotinib 150mg Tablets | 390 Days |
| Rociletinib 500mg Tablets | 274 Days | |||
| Rociletinib 625mg Tablets | 207 Days | |||
| NCT02296125 FLAURA | — | Median Progression Free Survival (PFS) (Months) At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression | Osimertinib 80 mg (China Cohort) | 17.8 Months |
| Osimertinib 80 mg (Global Cohort) | 18.9 Months | |||
| SoC EGFR-TKI (China Cohort) | 9.8 Months | |||
| SoC EGFR-TKI (Global Cohort) | 10.2 Months | |||
| NCT02296125 FLAURA | — | Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression | Osimertinib 80 mg (China Cohort) | 67.3 Percentage of Participants |
| Osimertinib 80 mg (China Cohort) | 46.9 Percentage of Participants | |||
| Osimertinib 80 mg (China Cohort) | 78.8 Percentage of Participants | |||
| Osimertinib 80 mg (Global Cohort) | 50.9 Percentage of Participants | |||
| Osimertinib 80 mg (Global Cohort) | 88.4 Percentage of Participants | |||
| Osimertinib 80 mg (Global Cohort) | 68.2 Percentage of Participants | |||
| SoC EGFR-TKI (China Cohort) | 25.8 Percentage of Participants | |||
| SoC EGFR-TKI (China Cohort) | 44.6 Percentage of Participants | |||
| SoC EGFR-TKI (China Cohort) | 72.3 Percentage of Participants | |||
| SoC EGFR-TKI (Global Cohort) | 42.3 Percentage of Participants | |||
| SoC EGFR-TKI (Global Cohort) | 75.2 Percentage of Participants | |||
| SoC EGFR-TKI (Global Cohort) | 24.4 Percentage of Participants | |||
| 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 | |||
| NCT02411448 RELAY | Carcinoma, Non-Small-Cell Lung | Number of Participants With Treatment-Emergent Adverse Events Cycle 1 Day 1 through End of Study (Up To 3 Years) | Part A: Ramucirumab + Erlotinib | 14 Participants |
| Part B: Placebo + Erlotinib | 225 Participants | |||
| Part B: Ramucirumab + Erlotinib | 221 Participants | |||
| NCT02411448 RELAY | Carcinoma, Non-Small-Cell Lung | Part B: Progression Free Survival (PFS) Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months) | Part B: Placebo+ Erlotinib | 12.4 Months |
| Part B: Ramucirumab+ Erlotinib | 19.4 Months | |||
| NCT02488330 | — | Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab Baseline through the end of trial (approximately 3 years) | Control and/or Onartuzumab Treatment | 0 Percent |
| NCT02588261 SOLAR | Carcinoma, Non-Small-Cell Lung | Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR) From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months) | ASP8273 | 9.26 months |
| Erlotinib or Gefitinib | 9.59 months | |||
| NCT02694536 | Pancreatic Neoplasms | Percentage of Participants With Adverse Events (AEs) Up to approximately 40 months (assessed continuously during treatment) | Erlotinib + Gemcitabine | 78.8 percentage of participants |