Lung Cancer, Nonsmall CellPhase 1/2NCT04691817
Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
A Phase 1/2 study testing Atezolizumab and Tocilizumab in people with Lung Cancer, Nonsmall Cell, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- What is being tested?
- Atezolizumab and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to Sep 2027
- Phase
- Phase 1/2
- 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
- Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
- Prior exposure to at least 1 line of therapy
- Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
- ECOG PS 0-2
Who cannot join
- Presence of a driver mutation that is susceptible to targeted therapy
- No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
- Other active invasive malignancy requiring ongoing therapy
- Evidence of progressing or untreated brain metastases
- Evidence or history of leptomeningeal disease
- Uncontrolled tumor related pain
- History of an autoimmune disease or IPF
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mel V, BA, 215-220-9703, Melissa.volpe@pennmedicine.upenn.edu
Melina Marmarelis, MD, MSCE
About this study
Official title: A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
- Conditions
- Lung Cancer, Nonsmall Cell
- Being tested
- Atezolizumab, Tocilizumab
- 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
1200mg infusion
TocilizumabDrug
Also called Actemra, RoActemra, RO4877533
Tocilizumab 6mg/kg or 4mg/kg infusion
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab and Tocilizumab | Experimental | Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days Receives: Drug: Atezolizumab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.
Measured: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.
Secondary outcomes (3)
Overall survival (OS)
Estimate the time from first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure
Measured: From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.
Dose Limiting Toxicities of the combination
Determine dose limiting toxicities of the combination
Measured: From first dose of protocol treatment until 49 days post treatment
Progression free survival (PFS).
Estimate the time from first dose of protocol treatment until first radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if there is no progression date registered.
Measured: From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start25 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Melina Marmarelis, MD, MSCE, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691817
- Sponsor's protocol ID
- UPCC 16520
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2020
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
- ClinicalTrials.gov ID
- NCT04691817
- Acronym / sponsor ID
- UPCC 16520
- Conditions
- Lung Cancer, Nonsmall Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab and Tocilizumab | Experimental | Drug: Atezolizumab, Drug: TocilizumabParticipants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
- Prior exposure to at least 1 line of therapy
- Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
- ECOG PS 0-2
Key exclusion criteria (7 listed)
- Presence of a driver mutation that is susceptible to targeted therapy
- No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
- Other active invasive malignancy requiring ongoing therapy
- Evidence of progressing or untreated brain metastases
- Evidence or history of leptomeningeal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: Tecentriq1200mg infusion | Drug | Atezolizumab and Tocilizumab |
| TocilizumabAlso: Actemra, RoActemra, RO4877533Tocilizumab 6mg/kg or 4mg/kg infusion | Drug | Atezolizumab and Tocilizumab |
Primary outcome
Overall response rate (ORR)
Time frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.
Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.
3 secondary outcomes
Overall survival (OS)
Time frame: From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.
Dose Limiting Toxicities of the combination
Time frame: From first dose of protocol treatment until 49 days post treatment
Progression free survival (PFS).
Time frame: From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer, Nonsmall Cell
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melina Marmarelis, MD, MSCE principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab and Tocilizumab in people with Lung Cancer, Nonsmall Cell, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
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?
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?
Contact Melissa Volpe, BA (215-220-9703, melissa.volpe@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.