Clinical Trials /

A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

NCT03819465

Description:

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)

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03819465

Trial Eligibility

Document

Title

  • Brief Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: D933IC00001
  • SECONDARY ID: 2018-001748-74
  • NCT ID: NCT03819465

Conditions

  • Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
DurvalumabMEDI4736A1
DanvatirsenAZD9150A2
OleclumabMEDI9447A3
MEDI5752A4
PemetrexedB1
CarboplatinB1
GemcitabineB1
CisplatinB1
Nab-paclitaxelB1

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
A1ExperimentalDurvalumab
  • Durvalumab
A2ExperimentalDurvalumab + danvatirsen
  • Durvalumab
  • Danvatirsen
A3ExperimentalDurvalumab + oleclumab
  • Durvalumab
  • Oleclumab
A4ExperimentalMEDI5752
  • MEDI5752
B1ExperimentalDurvalumab + Investigator's choice of chemotherapy
  • Durvalumab
  • Pemetrexed
  • Carboplatin
  • Gemcitabine
  • Cisplatin
  • Nab-paclitaxel
B2ExperimentalDurvalumab + Investigator's choice of chemotherapy + danvatirsen
  • Durvalumab
  • Danvatirsen
  • Pemetrexed
  • Carboplatin
  • Gemcitabine
  • Cisplatin
  • Nab-paclitaxel
B3ExperimentalDurvalumab + investigator's choice of chemotherapy + oleclumab
  • Durvalumab
  • Oleclumab
  • Pemetrexed
  • Carboplatin
  • Gemcitabine
  • Cisplatin
  • Nab-paclitaxel
B4ExperimentalMEDI5752
  • MEDI5752

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

          -  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
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assessment of AEs by CTCAE v5.0
Time Frame:From informed consent until the safety follow-up visit 3 months after the last dose of study drug
Safety Issue:
Description:Assessment of safety and tolerability of each treatment arm

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Approximately 24 months
Safety Issue:
Description:Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR or PR
Measure:Duration of Response (DoR)
Time Frame:On-study tumor assessments occur every 6-8 weeks until week 48-52, depending on treatment arm and then every 12 weeks thereafter until confirmed radiological progression, death, withdrawal of consent or study completion, up to approximately 24 months
Safety Issue:
Description:Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response until the date of objective radiological disease progression
Measure:Progression Free Survival (PFS)
Time Frame:Tumor assessments occur every 6-8 weeks until week 48-52 based on treatment arm & then every 12 weeks until progression, death, withdrawal or study completion up to 24 months. Further PFS data will be collected until 6 months post-last patient dosed
Safety Issue:
Description:Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of treatment assignment until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)
Measure:Overall Survival (OS)
Time Frame:Approximately 42 months. Additional OS data will be collected until approximately 6 months post-last patient dosed
Safety Issue:
Description:OS: Time from date of treatment assignment until the date of death by any cause
Measure:Blood concentration of durvalumab and novel oncology therapies
Time Frame:From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 3 months following treatment discontinuation
Safety Issue:
Description:Drug concentration of durvalumab and novel oncology therapies
Measure:Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
Time Frame:From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 6 months following treatment discontinuation
Safety Issue:
Description:Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:AstraZeneca

Trial 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

Last Updated

July 16, 2021