Eligibility, any sex, with EGFR Activating Mutation or Recurrent Non-Small Cell Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate in Patients With High PD-L1 Expressing Cancers After Failure of Targeted Therapy Defined as Complete or Partial Response According to the Investigator's AssessmentPrimary· Up to 1 year after failure of targeted therapy
Objective Response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). This outcome applies only to Arm I. \* Complete Response (CR): Disappearance of all target lesions, \* Partial Response (PR): At least a 30% decrease in the sum of the target lesions Progressive Disease (PD): At least a 20% increase in the sum of the target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease
Group
Value
95% CI
Arm I (Nivolumab, Pembrolizumab)
1
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
0
Arm I (Nivolumab, Pembrolizumab)
0
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
0
Number of Participants With Adverse Events Measured Using Common Terminology Criteria for Adverse Events Version 4.0Secondary· Adverse events were collected following each cycle of treatment (1-4) and up to 30 days after the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks.
Toxicities for each group will be estimated and described using counts and frequencies by grade, location and relatedness.
Group
Value
95% CI
Arm I (Nivolumab, Pembrolizumab)
1
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
1
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
3
Number of Mutations in Secondary Genes for Patients With PD-L1 Expression < 50%Secondary· Up to 1 year after failure of targeted therapy
This outcome applies to only Arms II and III.
Group
Value
95% CI
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
2
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
0
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
2
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
1
Objective Response Rates for Patients Without High PD-L1 Expressing CancersSecondary· Up to 3 years after failure of targeted therapy
Objective response rates will be estimated in the two PD-L1 expression \< 50% arms. At the time of protocol development, the intention was to estimate confidence intervals for each of these rates, and to make an exploratory comparison among the three groups comparing complete response/partial response versus stable disease/progressive disease among the groups using a Fisher's exact test (for the 2x3 table). Due to the low numbers of patients evaluable for response, these analyses were not performed.
Group
Value
95% CI
Arm I (Nivolumab, Pembrolizumab)
1
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
1
Arm I (Nivolumab, Pembrolizumab)
0
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
1
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
1
Overall SurvivalSecondary· From date of progression on primary targeted treatment to death, assessed up to 3 years.
Estimated using Kaplan-Meier methods and survival rates will be compared using log-rank tests.
Note: Log-rank tests will not be used due to the very low sample size.
Group
Value
95% CI
Arm I (Nivolumab, Pembrolizumab)
36
36 – 36
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
8.3
0.72 – 15.94
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
2.56
1.08 – 36
Rate of Tobacco Use and Mutation Burden Based on PD-L1 Expression at Time of ProgressionSecondary· Assessed at enrollment into study.
Smoking History was defined as Never, Former or Current
Group
Value
95% CI
Arm I (Nivolumab, Pembrolizumab)
1
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
2
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
1
Arm I (Nivolumab, Pembrolizumab)
0
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
2
Arm I (Nivolumab, Pembrolizumab)
0
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
0
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm I (Nivolumab, Pembrolizumab)
Serious: 0/1 (0%)
Deaths: 0/1
Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)
Serious: 1/1 (100%)
Deaths: 2/2
Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)
This phase II trial studies how well targeted therapy works in treating patients with incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07391774 — Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribocic
· Phase 3
· not yet recruiting
NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult
· Phase 2
· recruiting
NCT07392892 — A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
· Phase 2, PHASE3
· recruiting
NCT07288034 — Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatmen
· Phase 2
· recruiting
NCT07078604 — A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negati
· Phase 2
· recruiting
Other recruiting trials for EGFR Activating Mutation
Currently open trials in the same condition.
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· recruiting
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· Phase 1
· active not recruiting
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· Phase 2
· recruiting
NCT05948813 — TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
· Phase 2
· recruiting
NCT05768490 — Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastas
· Phase 3
· recruiting
Other Wake Forest University Health Sciences trials
Trials by the same sponsor.
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· NA
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 28 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02949843.