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Non-small Cell Lung CancerPhase 1NCT03064854

PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

A Phase 1 study testing PDR001, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 23 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
PDR001, Cisplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
23 sitesin 12 countries
Study dates
24 May 2017to 28 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Patient has stage IIIB (and is not a candidate for definitive multimodality therapy) or has stage IV NSCLC or relapsed locally advanced or metastatic NSCLC as follows:
  2. Group A, group B and group C only: Patients not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, targeted therapy, monoclonal antibody therapy including immunotherapy (e.g. PD-1/PD-L1 inhibitors) or targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion 4.
  3. Group D only: Patients who have received only one prior systemic therapy treatment consisting of a PD-1 and/or PD-L1 inhibitor with or without a CTLA4 inhibitor for NSCLC, with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion 4. The last dose of prior immunotherapy must have been administered at least 6 weeks prior to the start of study treatment (cycle 1 day 1).
  4. Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type, ALK-negative rearrangement and ROS1-negative rearrangement
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  6. Patients with at least 1 measurable tumor lesion as assessed by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) according to RECIST 1.1.

Main Exclusion Criteria:

  1. Patient with a history of severe hypersensitivity reaction to the planned study treatment including gemcitabine, paclitaxel, cisplatin, carboplatin, pemetrexed or any known excipients of these drugs
  2. History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
  3. Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
  4. History of leptomeningeal metastases
  5. Active, known or suspected autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll).
  6. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment

Trial locations and contacts

23 sites in 12 countries.

23 sites in 12 countries

United States5 sites

  • Henry Ford Health System SC

    Detroit, Michigan, 48202

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • UCLA Santa Monica Hematology / Oncology SC-2

    Santa Monica, California, 90404

  • Washington University School of Medicine SC

    St Louis, Missouri, 63110

  • Stanford Cancer Center SC

    Stanford, California, 94305

Other trials in United States

Italy3 sites

  • Novartis Investigative Site

    Aviano, PN, 33081

  • Novartis Investigative Site

    Meldola, FC, 47014

  • Novartis Investigative Site

    Rozzano, MI, 20089

Other trials in Italy

Spain3 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28041

Other trials in Spain

Belgium2 sites

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Roeselare, 8800

Other trials in Belgium

France2 sites

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13885

Other trials in France

Germany2 sites

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Göttingen, 37075

Other trials in Germany

Canada1 site

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Czechia1 site

  • Novartis Investigative Site

    Prague, 140 59

Other trials in Czechia

Hong Kong1 site

  • Novartis Investigative Site

    Pokfulam, Hong Kong

Other trials in Hong Kong

Netherlands1 site

  • Novartis Investigative Site

    Amsterdam, 1066 CX

Other trials in Netherlands

Singapore1 site

  • Novartis Investigative Site

    Singapore, 169610

Other trials in Singapore

South Korea1 site

  • Novartis Investigative Site

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)

The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.

Keywords
PDR001, immunotherapy, Non-small cell lung cancer, lung, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03064854
Study groupRoleWhat they receive
Group A: squamous, gem/cis+PDR001ExperimentalNot described
Receives: Drug: PDR001; Drug: Cisplatin; Drug: Gemcitabine
Group B: non-squamous, pem/cis+PDR001ExperimentalNot described
Receives: Drug: PDR001; Drug: Cisplatin; Drug: Pemetrexed
Group C: paclitaxel/carbo+PDR001ExperimentalNot described
Receives: Drug: PDR001; Drug: Carboplatin; Drug: Paclitaxel
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumabExperimentalNot described
Receives: Drug: PDR001; Drug: Cisplatin; Drug: Pemetrexed; Drug: Carboplatin; Drug: Canakinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy

    A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 42 days

    Measured: 42 days

  2. Overall response rate (ORR) per local investigator assessment for groups A, B and C

    ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 and local investigator assessment for groups A, B and C

    Measured: From baseline up to approximately 28 months

Secondary outcomes (14)

  1. Overall Response Rate (ORR) per local investigator assessment for group E

    ORR is defined as the proportion of patients with BOR of CR or PR, as per RECIST 1.1 and local investigator assessment for group E

    Measured: Up to approximately 28 months

  2. Progression Free Survival (PFS) per Investigator

    PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, as per RECIST 1.1 and local investigator assessment

    Measured: From start of treatment to the date of the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 28 months

  3. Disease Control Rate (DCR) per Investigator

    DCR is the proportion of patients with a BOR of CR or PR or stable disease (SD), as per RECIST 1.1 and local investigator assessment.

    Measured: Up to approximately 28 months

  4. Duration of Response (DOR) per Investigator

    DOR is defined by responders as the time between the date of first documented response (CR or PR) and the date of first documented progression (RECIST 1.1 and local investigator assessment) or death due any cause

    Measured: From date of first documented response to the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 28 months

  5. Time to Response (TTR) per Investigator

    TTR is defined as the time from the date of start of treatment to the first documented response of either CR or PR as per RECIST 1.1 and local investigator assessment

    Measured: From start of treatment to the date of the first documented reponse (CR or PR), assessed up to approximately 28 months

  6. Overall survival (OS)

    OS is defined as the time from date of start of treatment to date of death due to any cause.

    Measured: from date of start of treatment to date of death due to any cause (assessed up to approximately 3.5 years)

  7. Trough plasma Concentration (Ctrough) of PDR001

    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

    Measured: Pre-infusion on Day 1 of Cycle 1 to 4 of induction phase; pre-infusion on Day 1 of Cycle 1 to 4, 6, 8 and every 6 cycle afterwards of maintenance phase; Cycle = 21 Days

  8. Trough plasma Concentration (Ctrough) of chemotherapy

    Blood samples will be collected at indicated time points for pharmacokinetic analysis. Ctrough will be assessed for all chemotherapy agents: cysplatin, pemetrexed, carboplatin and gemcitabine

    Measured: Pre-infusion on Day 1 of Cycle 1, 3 and 4 of induction phase; Cycle = 21 Days

  9. Trough plasma Concentration (Ctrough) of canakinumab

    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

    Measured: Pre-infusion on Day 1 of Cycle 1, 3 and 4 of induction phase; Cycle = 21 Days

  10. PDR001 Antidrug antibodies (ADA) prevalence at baseline

    Blood samples will be collected at indicated time points for immunogenicity analysis.

    Measured: Baseline

  11. Canakinumab ADA prevalence at baseline

    Blood samples will be collected at indicated time points for immunogenicity analysis.

    Measured: Baseline

  12. PDR001 ADA incidence during treatment

    Blood samples will be collected at indicated time points for immunogenicity analysis.

    Measured: Pre-infusion on Day 1 of Cycle 1 to 4 of induction phase, pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 6, 8 and every 6 cycle afterwards of maintenance phase, end of treatment and 30 and 150-day post-treatment

  13. Canakinumab ADA incidence during treatment

    Blood samples will be collected at indicated time points for immunogenicity analysis.

    Measured: Pre-infusion on Day 1 of Cycle 1 and 4 of induction phase, pre-infusion on Day 1 of Cycle 6, 14 and 20 of maintenance phase, end of treatment and 30 and 150-day post-treatment

  14. Incidence of Adverse Events (AEs)

    Incidence of AEs (CTCAE v4.03)

    Measured: through study completion, up to approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2017
  2. Study start24 May 2017
  3. Primary completion28 Jul 2021
  4. Study completion28 Jul 2021

Why it stopped: Recruitment halted prematurely due to competitive landscape for lung cancer therapies

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03064854
Sponsor's protocol ID
CPDR001C2101
Other IDs
2016-002815-17, 2016
Status last verified
Aug 2022
First submitted
6 Feb 2017
Last updated
15 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Santoro A, Pilar G, Tan DSW, Zugazagoitia J, Shepherd FA, Bearz A, Barlesi F, Kim TM, Overbeck TR, Felip E, Cai C, Eddy S, McCulloch T, Schaefer ES. Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC. BMC Cancer. 2024 Oct 24;24(1):1307. doi: 10.1186/s12885-024-12841-2.

    PubMed 39448966

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PDR001, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 23 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Italy, Spain, Belgium, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment halted prematurely due to competitive landscape for lung cancer therapies). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03064854, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.

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