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AzTrials

Carcinoma, Non-Small Cell LungPhase 2CATHAYANCT04611776

A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

A Phase 2 study testing Atezolizumab, Carboplatin and Cisplatin in people with Carcinoma, Non-Small Cell Lung, run by Hoffmann-La Roche.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small Cell Lung
What is being tested?
Atezolizumab, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jul 2021to 8 Jan 2026
Phase
Phase 2
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

Who may be able to join

  • Complete resection (R0) and pathologically confirmed Stage IB to select IIIB NSCLC (8th edition)
  • Submission of pre-surgery blood sample and surgically resected tumor tissue slides or block
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Normal life expectancy excluding lung cancer mortality risk
  • Positive ctDNA status in plasma confirmed by central laboratory testing after surgical resection and prior to start of adjuvant therapy.

Who cannot join

  • Resected NSCLC with positive margins (R1 or R2)
  • NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
  • Mixed NSCLC and SCLC histology
  • Any prior therapy for lung cancer, including neoadjuvant therapy, or radiotherapy
  • NSCLC with an activating EGFR mutation or ALK fusion oncogene
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

About this study

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.

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.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.

  • PlaceboDrug

    Placebo will be administered intravenously during the induction phase and the maintenance phase.

  • CarboplatinDrug

    Carboplatin will be administered intravenously during the induction phase.

  • CisplatinDrug

    Cisplatin will be administered intravenously during the induction phase.

  • PemetrexedDrug

    Pemetrexed will be administered intravenously during the induction phase.

  • GemcitabineDrug

    Gemcitabine will be administered intravenously during the induction phase.

  • PaclitaxelDrug

    Paclitaxel will be administered intravenously during the induction phase.

Study groups in NCT04611776
Study groupRoleWhat they receive
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenanceExperimentalNot described
Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Paclitaxel
Arm B: Placebo + platinum-doublet followed by placebo maintenancePlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Paclitaxel

What is being measured

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

  1. ctDNA Clearance Rate at 6 Months

    ctDNA clearance rate at 6 months after randomization, defined as the proportion of participants with undetectable ctDNA at 6 months in the post-operative ctDNA+ participants.

    Measured: Randomization up to 6 months

  2. Disease-Free Survival (DFS)

    Disease-free survival (DFS), as assessed by the investigator, and defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First documented local or distant recurrence of non-small cell lung cancer (NSCLC) after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status; Occurrence of new primary NSCLC (non-small cell lung cancer); Death from any cause in the post-operative ctDNA+ participants

    Measured: Randomization up to approximatly 159 months

Secondary outcomes (9)

  1. ctDNA Clearance Rate at 12 Months

    ctDNA clearance rate in post-operative ctDNA+ participants.

    Measured: Randomization up to 12 months

  2. Overall ctDNA Clearance Rate

    Overall ctDNA clearance rate in post-operative ctDNA+ participants.

    Measured: Randomization up to approximately 159 months

  3. Duration of ctDNA Clearance

    Duration of ctDNA clearance, defined as the time from the first documented ctDNA clearance to ctDNA detection, investigator-assessed radiographic or biopsy confirmed disease recurrence, or death from any cause, whichever occurs first in post-operative ctDNA+ participants.

    Measured: Up to approximatly 159 months

  4. Overall survival (OS)

    Overall survival (OS) after randomization, defined as the time from randomization to death from any cause in the post-operative ctDNA+ participants.

    Measured: Randomization to death from any cause (up to approximately 159 months)

  5. DFS Rate

    DFS rate at 2 years and 3 years, defined as the probability that a participant has not experienced disease recurrence, a new primary NSCLC, or death from any cause, as determined by the investigator at 2 years and 3 years, respectively in the post-operative ctDNA+ participants.

    Measured: Randomization to 2 years and 3 years

  6. Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population

    Overall ctDNA clearance rate in the PD-L1 TC>=1% (Ventana SP263) population in the post-operative ctDNA+ participants.

    Measured: Randomization up to approximately 159 months

  7. OS Rate

    OS rate at 2 years and 3 years, defined as the probability that a patient has not experienced death from any cause at 2 years and 3 years, respectively in the post-operative ctDNA+ participants.

    Measured: Randomization to 2 years and 3 years

  8. Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)

    Time to confirmed deterioration (TTCD) in patient-reported functioning and global health (GHS)/quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) in the post-operative ctDNA+ participants.

    Measured: Up to approximately 159 months

  9. Percentage of Pariticipants with Adverse Events

    Percentage of participants with adverse events in the post-operative ctDNA+ participants.

    Measured: Randomization up to approximatly 159 months

Timeline

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

  1. First posted2 Nov 2020
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion6 Mar 2025 (estimated)
  4. Study completion8 Jan 2026 (estimated)

Why it stopped: The positive results from IMpower010 demonstrated benefit by adding atezolizumab as adjuvant therapy in early stage NSCLC. These results raised ethical concerns of enrolling pts to best supportive care over checkpoint inhibition in this setting.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611776
Sponsor's protocol ID
YO41867
Acronym
CATHAYA
Status last verified
Jun 2021
First submitted
30 Oct 2020
Last updated
16 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Carboplatin and Cisplatin in people with Carcinoma, Non-Small Cell Lung, run by Hoffmann-La Roche.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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?

ctDNA Clearance Rate at 6 Months (time frame: Randomization up to 6 months). 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 NCT04611776.

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 16 Jun 2021.

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