TriangleNCT03735121 · CITED IN SOURCE DOCUMENTS
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-12-05
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1
Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1
Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1
Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab
Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab
Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
Part 1: Percentage of Participants With Adverse Events (AEs)
Part 2: Percentage of Participants With AEs
Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab
Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab
Part 2: Objective Response Rate (ORR)
Part 2: Progression-free Survival (PFS)
Part 2: Overall Survival (OS)
Part 2: Duration of Response (DOR)
Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score
Part 2: Change From Baseline in EORTC IL57 Role Functioning Score
Part 2: Change From Baseline in EORTC IL57 Global Health Status Score
Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57
Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration
Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration
Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire
Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire
Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire
Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire
Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire
Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic NSCLC * Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen. * Measurable disease as defined by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Uncontrolled or symptomatic hypercalcemia * Pregnancy or breastfeeding * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * Severe infection ≤ 4 weeks * Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * Treatment with a live, attenuated vaccine ≤ 4 weeks * Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug * Treatment with systemic immunosuppressive medication ≤ 2 weeks Additional Exclusion Criteria (Part 2 Only) • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Atezolizumab
- intervention Names
- Drug: Atezolizumab
- label
- Atezolizumab (Part 2)
- type
- EXPERIMENTAL
- description
- Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab
- intervention Names
- Drug: Atezolizumab
- Drug: rHuPH20
- label
- Cohort 1: Atezolizumab+rHuPH20 (Part 1)
- type
- EXPERIMENTAL
- description
- Atezolizumab+rHuPH20, followed by Atezolizumab
- intervention Names
- Drug: Atezolizumab
- Drug: rHuPH20
- label
- Cohort 2: Atezolizumab+rHuPH20 (Part 1)
- type
- EXPERIMENTAL
- description
- Atezolizumab+rHuPH20, followed by Atezolizumab
- intervention Names
- Drug: Atezolizumab
- Drug: rHuPH20
- label
- Cohort 3: Atezolizumab+rHuPH20(Part 1)
- type
- EXPERIMENTAL
- description
- Atezolizumab + rHuPH20
- intervention Names
- Drug: Atezolizumab
- Drug: rHuPH20
- label
- Atezolizumab + rHuPH20 (Part 2)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Atezolizumab (Part 2)
- Atezolizumab + rHuPH20 (Part 2)
- Cohort 1: Atezolizumab+rHuPH20 (Part 1)
- Cohort 2: Atezolizumab+rHuPH20 (Part 1)
- Cohort 3: Atezolizumab+rHuPH20(Part 1)
- description
- Atezolizumab will be administered as per the schedule specified in arm or cohort.
- name
- Atezolizumab
- other Names
- Tecentriq
- type
- DRUG
- arm Group Labels
- Atezolizumab + rHuPH20 (Part 2)
- Cohort 1: Atezolizumab+rHuPH20 (Part 1)
- Cohort 2: Atezolizumab+rHuPH20 (Part 1)
- Cohort 3: Atezolizumab+rHuPH20(Part 1)
- description
- rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
- name
- rHuPH20
- other Names
- ENHANZE
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- SEQUENTIAL
- intervention Model Description
- Intervention study model can be sequential or in parallel.
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 438
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1
- time Frame
- Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2)
- measure
- Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1
- time Frame
- Predose on Day 1 of Cycle 2 (Cycle length =21 days)
- measure
- Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1
- time Frame
- From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days)
- secondary Outcomes
- measure
- Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
- time Frame
- Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)
- measure
- Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab
- time Frame
- Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)
- measure
- Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab
- time Frame
- Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2)
- description
- Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.
- measure
- Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
- time Frame
- Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3
- description
- An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place.
- measure
- Part 1: Percentage of Participants With Adverse Events (AEs)
- time Frame
- From initiation of study treatment up to approximately 69 months
- description
- An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place.
- measure
- Part 2: Percentage of Participants With AEs
- time Frame
- From initiation of study treatment up to approximately 44.7 months
- measure
- Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
- time Frame
- Cycle 1 (Cycle length=21 days)
- description
- 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.
- measure
- Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab
- time Frame
- Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
- description
- 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo
- measure
- Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab
- time Frame
- Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
- description
- ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place.
- measure
- Part 2: Objective Response Rate (ORR)
- time Frame
- Up to approximately 25 months
- description
- PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method.
- measure
- Part 2: Progression-free Survival (PFS)
- time Frame
- Up to approximately 25 months
- description
- OS was defined as the time from the date of study randomization to the date of death from any cause.
- measure
- Part 2: Overall Survival (OS)
- time Frame
- Up to approximately 44.7 months
Full study description
- brief Summary
- This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Source references
- references
- citation
- Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Felip E, Majem M, Korbenfeld E, Kolb-Sielecki J, Isla D, Barata T, Bustillos A, Herraez-Baranda LA, Tosti N, Young F, Zanghi J, Cappuzzo F. Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Lung Cancer. 2026 Jul;217:109452. doi: 10.1016/j.lungcan.2026.109452. Epub 2026 May 12.
- pmid
- 42214243
- type
- DERIVED
- citation
- Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Herraez-Baranda LA, Shearer-Kang E, Liu X, Tosti N, Williams P, Castro Sanchez AY, Zanghi J, Felip E. Brief Report: Updated Data From IMscin001 Part 2, a Randomized Phase III Study of Subcutaneous Versus Intravenous Atezolizumab in Patients With Locally Advanced or Metastatic NSCLC. J Thorac Oncol. 2024 Oct;19(10):1460-1466. doi: 10.1016/j.jtho.2024.05.005. Epub 2024 May 9.
- pmid
- 38729426
- type
- DERIVED
- citation
- Burotto M, Zvirbule Z, Mochalova A, Runglodvatana Y, Herraez-Baranda L, Liu SN, Chan P, Shearer-Kang E, Liu X, Tosti N, Zanghi JA, Leutgeb B, Felip E. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023 Aug;34(8):693-702. doi: 10.1016/j.annonc.2023.05.009. Epub 2023 Jun 1.
- pmid
- 37268157
- type
- DERIVED
- citation
- Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, Maiya V, Chan P, Pozzi E, Marchand M, Monchalin M, Tanaka K, Tosti N, Wang B, Restuccia E. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155. doi: 10.1002/cpdd.936. Epub 2021 Mar 31.
- pmid
- 33788415
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-89abd8e8a4279fcdc4f3
- requested nct id
- NCT03735121
- primary nct id
- NCT03735121
- source kind
- fda_spl_label
- source record id
- 87c7ca7b-0b4e-456a-8338-80c9613edb36
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- payload sha256
- 04c428fd6ba4e06a21bfa4a62f9f2404b3f199eabcbed054c88caa9216ede74b
- payload
- application numbers
- BLA761347
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-89abd8e8a4279fcdc4f3
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03735121
- occurrences
- context exact
- 14 CLINICAL STUDIES 14.1 Non-Small Cell Lung Cancer NSCLC - TECENTRIQ HYBREZA IMscin001 (NCT03735121) was an open-label, multi-center, international, randomized study conducted in adult patients with locally advanced or metastatic NSCLC who were not exposed to
- end
- 100
- exact text
- NCT03735121
- start
- 89
- context exact
- reached in the intravenous atezolizumab arm and 18.4 months, not reached in the placebo arm). Figure 11 Figure 12 14.7 Patient Experience The IMscin002 study (NCT03735121) was a randomized, multi-center, open-label cross-over trial conducted in 179 patients with either PD-L1-positive early-stage NSCLC receiving adjuvant treatmen
- end
- 57873
- exact text
- NCT03735121
- start
- 57862
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00500.json
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- source json pointer
- /results/4/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 87c7ca7b-0b4e-456a-8338-80c9613edb36
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 7749bbeab1cb94c0f70463dfb63f7695d79c0493295eb253176c583eaf254925
- spl effective time
- 20260520
- spl set id
- a617b089-ce66-464b-987b-b45d029b4d6f
Preserved source evidence · Not medical advice