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NeoplasmsPhase 3NCT05112965

An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)

A Phase 3 study testing Atezolizumab, Bevacizumab and Pemetrexed in people with Neoplasms, run by Hoffmann-La Roche at 17 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, multicenter, non-randomized extension study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and do not have access to the study… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Atezolizumab, Bevacizumab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
17 sitesChina
Study dates
1 Dec 2021to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Eligible for continuing or crossing over to atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol, or
  • Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
  • First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
  • Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of rollover from the parent study as assessed by the investigator
  • Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Who cannot join

  • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
  • Study treatment is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
  • Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (±7 days) allowed in the parent study
  • Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
  • Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study (if applicable)
  • Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
Show all 10Show fewer
  • Ongoing serious adverse events that have not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in the extension study
  • Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the patient at high risk for treatment-related complications
  • Concurrent participation in any therapeutic clinical trial (other than the parent study)
  • Pregnant or lactating, or intending to become pregnant during the extension study

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Changchun Cancer Hospital

    Changchun, 130000

  • Jilin Cancer Hospital

    Changchun, 132013

  • Hunan Cancer Hospital

    Changsha, 410013

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Shanghai Chest Hospital

    Shanghai, 200000

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, 300211

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center

    Wuhan, Hubei, 430022

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

About this study

Official title: An Open-Label, Multicenter Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)

This is an open-label, multicenter, non-randomized extension study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and do not have access to the study treatment locally, continue to receive study treatment in this extension study.

Conditions
Neoplasms
Medical subject headings
Neoplasms

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 as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study at the time of participant discontinuation from the parent study closure.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered as directed per the parent study.

  • PemetrexedDrug

    Pemetrexed will be administered as directed per the parent study.

  • PaclitaxelDrug

    Paclitaxel will be administered as directed per the parent study.

  • EnzalutamideDrug

    Also called Xtandi

    Enzalutamide will be administered as directed per the parent study.

Study groups in NCT05112965
Study groupRoleWhat they receive
Atezolizumab MonotherapyExperimentalParticipants will continue to receive atezolizumab monotherapy as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
Receives: Drug: Atezolizumab
Combined Agents with AtezolizumabExperimentalParticipants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Enzalutamide
Comparator TreatmentActive comparatorParticipants will continue to receive comparator agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
Receives: Drug: Bevacizumab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Enzalutamide

What is being measured

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

  1. Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)

    Measured: Up to approximately 4 years

Secondary outcomes (2)

  1. Percentage of Participants With Serious Adverse Events (SAEs)

    Measured: Up to 90 days after the final dose of study treatment (up to approximately 4 years)

  2. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Measured: Up to 90 days after the final dose of study treatment (up to approximately 4 years)

Timeline

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

  1. First posted9 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112965
Sponsor's protocol ID
YO42713
Status last verified
Sep 2026
First submitted
2 Nov 2021
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Bevacizumab and Pemetrexed in people with Neoplasms, run by Hoffmann-La Roche at 17 sites in China.

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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s) (time frame: Up to approximately 4 years). 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 NCT05112965.

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 30 Sep 2026.

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