Trial Outcomes & Findings for Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), ARCHON-1 Trial (NCT NCT03801902)

NCT ID: NCT03801902

Last Updated: 2025-09-23

Results Overview

Safety event is defined as one of the following: * Grade 4-5 non-hematologic protocol-defined serious adverse event (SAE) possibly, probably, or definitely related to protocol treatment occurring within 90 days from radiation therapy (RT) start for Arm 1 or within 8 weeks from RT start for Arm 2; * Any adverse event possibly, probably, or definitely related to protocol treatment that leads to missing at least 2 doses of durvalumab within 90 days from RT start for Arm 1 or within 8 weeks from RT start for Arm 2; * Permanent discontinuation of durvalumab due to an adverse event possibly, probably, or definitely related to protocol treatment within the first 30 days of starting durvalumab; or * SAEs possibly, probably, or definitely related to RT that cause either an interruption or early termination of RT. Adverse events are graded according to the Common Terminology Criteria for Adverse Events version 5.0, which assigns a grade according to severity from 1=mild to 5=death.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

From start of study treatment to 90 (ACRT) or 56 (standard RT) days from the end of radiation treatment. (Approximately 104 or 70 days, respectively, from start of study treatment)

Results posted on

2025-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (CLOSED) (Durvalumab and ACRT) Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Overall Study STARTED	14	12
Overall Study Analyzable for Safety Events	12	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (CLOSED) (Durvalumab and ACRT) Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm III (Durvalumab, Monalizumab, Standard RT) Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes and monalizumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm IV (Durvalumab, Oleclumab, Standard RT) Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Patients also receive oleclumab IV over 60 minutes on days 1 and 15 of cycles 1-2, then on day 1 of cycles thereafter. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Overall Study Did not receive protocol treatment.	1	0	0	0

Baseline Characteristics

Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), ARCHON-1 Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=13 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Total n=25 Participants Total of all reporting groups
Age, Continuous	69 years n=93 Participants	72 years n=4 Participants	69 years n=27 Participants
Age, Customized 50-59 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Customized 60-69 years	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Age, Customized ≥ 70 years	3 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Zubrod Performance Status 0	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Zubrod Performance Status 1	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Programmed death-ligand 1 (PD-L1) Value 50%-60%	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Programmed death-ligand 1 (PD-L1) Value 70%-80%	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Programmed death-ligand 1 (PD-L1) Value >80%	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
American Joint Committee on Cancer (AJCC) 8th ed. Stage IIIA	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
American Joint Committee on Cancer (AJCC) 8th ed. Stage IIIB	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
American Joint Committee on Cancer (AJCC) 8th ed. Stage IIIC	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
American Joint Committee on Cancer (AJCC) 8th ed. Stage N1-Undectable primary	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: From start of study treatment to 90 (ACRT) or 56 (standard RT) days from the end of radiation treatment. (Approximately 104 or 70 days, respectively, from start of study treatment)

Population: Analyzable for safety events

Outcome measures

Outcome measures
Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Number of Participants Experiencing a Safety Event	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From start of durvalumab to 8 weeks

Population: Eligible participants accrued to arm I or arm II.

Outcome measures

Outcome measures
Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=13 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Percentage of Participants Who Received at Least 80% of Planned Durvalumab Dose During First 8 Weeks Following Initial Dose	84.6 percentage of participants Interval 54.6 to 98.1	75.0 percentage of participants Interval 42.8 to 94.5

SECONDARY outcome

Timeframe: From start of monalizumab or oleclumab to 8 weeks

Population: Eligible participants on arms III and IV. No participants accrued to these arms.

An observation of at least 80% of patients who received at least 80% of the planned dose is considered to be evidence that the given regimen is feasible in this setting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to last follow-up at time of initial analysis. Maximum follow-up was 23.2 months

Population: Eligible participants

Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 grades adverse event severity from 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Outcome measures

Outcome measures
Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=13 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Distribution of Participants by Highest Grade Adverse Event Grade 1	2 Participants	0 Participants
Distribution of Participants by Highest Grade Adverse Event Grade 2	5 Participants	3 Participants
Distribution of Participants by Highest Grade Adverse Event Grade 3	4 Participants	8 Participants
Distribution of Participants by Highest Grade Adverse Event Grade 4	1 Participants	0 Participants
Distribution of Participants by Highest Grade Adverse Event Grade 5	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From registration to last follow-up at time of initial analysis. Maximum follow-up was 23.2 months.

Population: Eligible participants

Outcome measures

Outcome measures
Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=13 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Percentage of Participants Experiencing a Grade 4 or Higher Non-hematologic Adverse Event	7.7 percentage of participants Interval 0.2 to 36.0	8.3 percentage of participants Interval 0.2 to 38.5

SECONDARY outcome

Timeframe: From registration to two years after protocol treatment, which lasted up to 12 months. Maximum follow-up was 38.3 months.

Population: Eligible participants

Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as an increase \>= 20% of the sum of longest diameters of target lesions compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Analysis was planned to occur two years after end of protocol treatment, which could last up to 12 months. No formal testing was planned due to a lack of statistical power.

Outcome measures

Outcome measures
Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=13 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 Participants Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Progression-free Survival	20.4 months Interval 7.9 to There here were not enough events to estimate the upper confidence boundary.	30.2 months Interval 8.2 to There here were not enough events to estimate the upper confidence boundary.

Adverse Events

Arm I (CLOSED) (Durvalumab and ACRT)

Serious events: 6 serious events

Other events: 13 other events

Deaths: 4 deaths

Arm II (CLOSED) (Durvalumab and Standard RT)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm I (CLOSED) (Durvalumab and ACRT) n=13 participants at risk Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.	Arm II (CLOSED) (Durvalumab and Standard RT) n=12 participants at risk Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	16.7% 2/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Cardiac disorders Atrial flutter	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Infections and infestations Infections and infestations - Other	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Infections and infestations Lung infection	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	8.3% 1/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Investigations Alanine aminotransferase increased	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Investigations Cardiac troponin T increased	0.00% 0/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	8.3% 1/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Investigations Ejection fraction decreased	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Renal and urinary disorders Renal calculi	0.00% 0/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	8.3% 1/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	8.3% 1/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	16.7% 2/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.7% 1/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	0.00% 0/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	8.3% 1/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.
Vascular disorders Hypertension	0.00% 0/13 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.	8.3% 1/12 • From registration to two years after protocol treatment, which lasted up to 12 months. This time frame corresponds to the last outcome measure analyzed, progression-free survival.