Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) - PACIFIC-4/RTOG-3515

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002572-41-GB

Enrollment

706

Registered

2019-01-21

Start date

2019-03-13

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer MedDRA version: 21.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864

Interventions

Product Name: durvalumab Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy 3. Planned SoC SBRT as definitive treatment 4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2 5. Life expectancy of at least 12 weeks 6. Body weight >30 kg 7. Submission of available tumor tissue sample 8. Adequate organ and marrow function required 9. Patients with central or peripheral lesions are eligible 10. Staging studies must be done within 10 weeks before randomization 11. Pulmonary Function Testing within 12 weeks of randomization 12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively with surgery only or SBRT only >1 year prior to enrollment are eligible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: 1. Mixed small cell and non-small cell cancer 2. History of allogeneic organ transplantation 3. History of another primary malignancy with exceptions 4. History of active primary immunodeficiency 5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade =2 from SBRT (Stereotactic Body Radiation Therapy)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with subset of T1-T3N0 NSCLC.;Secondary Objective: To assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of PFS for all stage I/II NSCLC patients.To assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of OS in patients with subset of T1-T3N0 NSCLC.To assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of OS in patients with Stage I/II NSCLC.To further assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of lung cancer-specific mortality.To further assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of PFS24, TTP, TTDM, PFS2.To assess the PK of durvalumab.To investigate the immunogenicity of durvalumab.To assess symptoms and health-related quality of life in patients treated with durvalumab with SBRT compared to placebo with SBRT using the EORTC QLQ-C30.To assess the safety and tolerability profile of durvalumab with SBRT compared to placebo with SBRT;Primary end point(s): PFS in patients with subset of T1-T3N0 by BICR ;Timepoint(s) of evaluation of this end point: On-study tumor assessments occur 8 weeks after randomization, then every 12 weeks through week 116, then every 16 weeks through 3 years after randomization, then every 6 months thereafter until objective disease progression.	—

Measure

Time frame

Main Objective: To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with subset of T1-T3N0 NSCLC.;Secondary Objective: To assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of PFS for all stage I/II NSCLC patients.To assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of OS in patients with subset of T1-T3N0 NSCLC.To assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of OS in patients with Stage I/II NSCLC.To further assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of lung cancer-specific mortality.To further assess the efficacy of durvalumab with SBRT compared to placebo with SBRT in terms of PFS24, TTP, TTDM, PFS2.To assess the PK of durvalumab.To investigate the immunogenicity of durvalumab.To assess symptoms and health-related quality of life in patients treated with durvalumab with SBRT compared to placebo with SBRT using the EORTC QLQ-C30.To assess the safety and tolerability profile of durvalumab with SBRT compared to placebo with SBRT;Primary end point(s): PFS in patients with subset of T1-T3N0 by BICR ;Timepoint(s) of evaluation of this end point: On-study tumor assessments occur 8 weeks after randomization, then every 12 weeks through week 116, then every 16 weeks through 3 years after randomization, then every 6 months thereafter until objective disease progression.

—

Secondary

Measure	Time frame
Secondary end point(s): PFS in patients with T1-T3N0 NSCLC OS in patients with subset of T1-T3N0 NSCLC OS in patients with T1 to T3N0M0 NSCLC Lung cancer mortality PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1 PFS2 using local assessment Concentration of durvalumab in blood Presence of ADA for durvalumab EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life Safety and tolerability: AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings;Timepoint(s) of evaluation of this end point: OS: from randomization until death due to any cause Lung cancer mortality: time from randomization until death due to lung cancer PFS24: 24 months TTP: time from randomization until progression (excluding deaths) TTDM: time from randomization until death or distant metastasis PFS2: time from randomization to second progression (local assessment) ADA: will be collected at Baseline, at cycles 1, 8, 14, 26, 100 then months 3 and 6 after completed/discontinued study treatment EORTC QLQ-C30: Screening, at Baseline, Week 2, 4, 6, 8, 12, 16 and 20 weeks after randomization, then every 8 weeks until 3 years after randomization, then every 6 months until PFS2 Safety and tolerability - from randomization until 3 months after treatment discontinuation	—

Measure

Time frame

Secondary end point(s): PFS in patients with T1-T3N0 NSCLC OS in patients with subset of T1-T3N0 NSCLC OS in patients with T1 to T3N0M0 NSCLC Lung cancer mortality PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1 PFS2 using local assessment Concentration of durvalumab in blood Presence of ADA for durvalumab EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life Safety and tolerability: AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings;Timepoint(s) of evaluation of this end point: OS: from randomization until death due to any cause Lung cancer mortality: time from randomization until death due to lung cancer PFS24: 24 months TTP: time from randomization until progression (excluding deaths) TTDM: time from randomization until death or distant metastasis PFS2: time from randomization to second progression (local assessment) ADA: will be collected at Baseline, at cycles 1, 8, 14, 26, 100 then months 3 and 6 after completed/discontinued study treatment EORTC QLQ-C30: Screening, at Baseline, Week 2, 4, 6, 8, 12, 16 and 20 weeks after randomization, then every 8 weeks until 3 years after randomization, then every 6 months until PFS2 Safety and tolerability - from randomization until 3 months after treatment discontinuation

—

Countries

Belgium, Canada, China, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactInformation Center

AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026