Trial Outcomes & Findings for Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients (NCT NCT04512430)
NCT ID: NCT04512430
Last Updated: 2025-04-02
Results Overview
To determine the antitumor activity in terms of objective response rate (ORR) of neoadjuvant treatment with carboplatin-pemetrexed-bevacizumab plus atezolizumab for the treatment of locally advanced and potentially resectable NSCLC patients with EGFR mutations. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
From date of end of neoadjuvant treatment until the date of last follow up, assessed up to 36 months
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
Experimental: Neo-Adjuvant Immunotherapy
Neoadjuvant treatment: (Atezolizumab: 1200 mg, IV infusion+ Bevacizumab: 15mg/Kg mg, IV infusion+Carboplatin: AUC6, IV infusion+ Pemetrexed: 500 mg/m2, IV infusion) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day intervals (QW3) prior to surgery.Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
Surgery: Surgery must be done within the 4th week
Adjuvant treatment: Atezolizumab: 1200 mg, IV infusion Q4W for 6 months (6 cycles) Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week from surgery and for 6 months (6 cycles).
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients
Baseline characteristics by cohort
| Measure |
Experimental: Neo-Adjuvant Immunotherapy
n=4 Participants
Neoadjuvant treatment: (Atezolizumab: 1200 mg, IV infusion+ Bevacizumab: 15mg/Kg mg, IV infusion+Carboplatin: AUC6, IV infusion+ Pemetrexed: 500 mg/m2, IV infusion) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day intervals (QW3) prior to surgery.Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
Surgery: Surgery must be done within the 4th week
Adjuvant treatment: Atezolizumab: 1200 mg, IV infusion Q4W for 6 months (6 cycles) Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week from surgery and for 6 months (6 cycles).
|
|---|---|
|
Age, Continuous
|
66.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=99 Participants
|
|
Smoking status
Never smoker (<= 100 cigarettes/lifetime)
|
3 Participants
n=99 Participants
|
|
Smoking status
Former smoker (>= 1 year)
|
1 Participants
n=99 Participants
|
|
Smoking status
Active smoker
|
0 Participants
n=99 Participants
|
|
Performance status
ECOG 0
|
2 Participants
n=99 Participants
|
|
Performance status
ECOG 1
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From date of end of neoadjuvant treatment until the date of last follow up, assessed up to 36 monthsPopulation: Intention to treat
To determine the antitumor activity in terms of objective response rate (ORR) of neoadjuvant treatment with carboplatin-pemetrexed-bevacizumab plus atezolizumab for the treatment of locally advanced and potentially resectable NSCLC patients with EGFR mutations. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Experimental: Neo-Adjuvant Immunotherapy
n=4 Participants
Neoadjuvant treatment: (Atezolizumab: 1200 mg, IV infusion+ Bevacizumab: 15mg/Kg mg, IV infusion+Carboplatin: AUC6, IV infusion+ Pemetrexed: 500 mg/m2, IV infusion) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day intervals (QW3) prior to surgery.Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
Surgery: Surgery must be done within the 4th week
Adjuvant treatment: Atezolizumab: 1200 mg, IV infusion Q4W for 6 months (6 cycles) Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week from surgery and for 6 months (6 cycles).
|
|---|---|
|
Overall Response
Partial Response (PD)
|
1 Participants
|
|
Overall Response
Stable Disease (SD)
|
2 Participants
|
|
Overall Response
Progression Disease (PD)
|
1 Participants
|
Adverse Events
Experimental: Neo-Adjuvant Immunotherapy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Neo-Adjuvant Immunotherapy
n=4 participants at risk
Neoadjuvant treatment: (Atezolizumab: 1200 mg, IV infusion+ Bevacizumab: 15mg/Kg mg, IV infusion+Carboplatin: AUC6, IV infusion+ Pemetrexed: 500 mg/m2, IV infusion) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day intervals (QW3) prior to surgery.Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
Surgery: Surgery must be done within the 4th week
Adjuvant treatment: Atezolizumab: 1200 mg, IV infusion Q4W for 6 months (6 cycles) Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week from surgery and for 6 months (6 cycles).
|
|---|---|
|
Surgical and medical procedures
Right lung hernia
|
25.0%
1/4 • Number of events 1 • 40 months
|
Other adverse events
| Measure |
Experimental: Neo-Adjuvant Immunotherapy
n=4 participants at risk
Neoadjuvant treatment: (Atezolizumab: 1200 mg, IV infusion+ Bevacizumab: 15mg/Kg mg, IV infusion+Carboplatin: AUC6, IV infusion+ Pemetrexed: 500 mg/m2, IV infusion) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day intervals (QW3) prior to surgery.Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
Surgery: Surgery must be done within the 4th week
Adjuvant treatment: Atezolizumab: 1200 mg, IV infusion Q4W for 6 months (6 cycles) Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week from surgery and for 6 months (6 cycles).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
75.0%
3/4 • Number of events 3 • 40 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
2/4 • Number of events 2 • 40 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Number of events 2 • 40 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • Number of events 2 • 40 months
|
|
Investigations
Neutrophil count decreased
|
100.0%
4/4 • Number of events 5 • 40 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 3 • 40 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 2 • 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Gastrointestinal disorders
Gingival pain
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Infections and infestations
COVID 19
|
50.0%
2/4 • Number of events 2 • 40 months
|
|
Gastrointestinal disorders
Mucositis oral
|
75.0%
3/4 • Number of events 3 • 40 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • 40 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • 40 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
25.0%
1/4 • Number of events 1 • 40 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place