Clinical trial NCT03819465: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
Official title: A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic Non-Small Cell Lung Cancer (NSCLC)
Keywords: First-Line Stage IV Metastatic Non-Small Cell Lung Cancer
Stage IV Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Non-Small Cell Lung
Non-Small Cell
NSCLC
Non-Small Cell Lung Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment arms for MEDI5752 (Arms A4 and B4) will enroll 42 and 60 patients, respectively. Arm B5 (AZD2936+chemotherapy) will enroll 60 patients.

For all other treatment arms, 30 patients will be enrolled into each arm; additional patients may be enrolled in order to have 30 evaluable patients per arm (ie, dosed).
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)

Detailed description: This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
* No prior chemotherapy or any other systemic therapy for metastatic NSCLC
* Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred \>12 months from end of last therapy
* Known tumor PD-L1 status
* Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
* WHO/ECOG status at 0 or 1 at enrollment
* Life expectancy of at least 12 weeks
* Troponin I or T ≤ ULN (per institutional guidelines)

Exclusion Criteria:

* Active or prior documented autoimmune or inflammatory disorders
* History of active primary immunodeficiency
* Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
* Untreated CNS metastases

Primary outcomes:
measure: Assessment of AEs by CTCAE v5.0
timeFrame: From informed consent until the safety follow-up visit 3 months after the last dose of study drug, or until the final data cut-off (DCO) date, whichever is earlier.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized).
measure: Duration of Response (DoR)
timeFrame: Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized).
measure: Progression Free Survival (PFS)
timeFrame: Tumor assessments every 6-9 weeks until week 48-54, then every 12/18 weeks based on arm until progression, death, withdrawal or final DCO. Further PFS data will be collected until 6 months after last patient dosed or final DCO
measure: Overall Survival (OS)
timeFrame: OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier.
measure: Blood concentration of durvalumab and novel oncology therapies
timeFrame: From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 cycles (except for Arms A5 & B5), at end of treatment (Arms A4 & B4, A5 & B5 only), and until 3 months following treatment discontinuation, or the final DCO date.
measure: Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
timeFrame: From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 or 6 cycles (except for arms A5&B5), at end of treatment (arms A4&B4, A5&B5 only), until 3/6 months after treatment discontinuation, or the final DCO date.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Salzburg
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Cheongju-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Grudziądz
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Tomaszów Mazowiecki
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Sankt-Peterburg
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
Study officials:
affiliation: UCSD Morres Cancer Center
name: Sandip Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chih-Hsin Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: