Phase 3
Completed N=438
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT03735121 ↗Enrolled (actual)
438
Serious AEs
22.6%
Results posted
Jun 2023
Primary outcomePrimary: Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 — 121; 77.5; 78.3 micrograms per milliliter (μg/mL)
◆ Published Evidence
Established
50citations · ~17 / year
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.
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.
Linked Publications (4)
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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.
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Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
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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.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 |
121; 77.5; 78.3 | — |
| PRIMARY Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1 |
85.4; 89.4 | — |
| PRIMARY Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1 |
3327.9; 2907.1 | — |
| SECONDARY Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab |
251; 129; 181 | — |
| SECONDARY Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab |
3.02; 3.45; 3.92 | — |
| SECONDARY Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab |
3870; 1410; 2820 | — |
| SECONDARY Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration |
NA; NA; NA; 116; 61.7; 108 | — |
| SECONDARY Part 1: Percentage of Participants With Adverse Events (AEs) |
100; 86.7; 84.6 | — |
| SECONDARY Part 2: Percentage of Participants With AEs |
85.5; 89.9 | — |
| SECONDARY Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1 |
88.7; 97.2 | — |
| SECONDARY Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab |
179; 205 | — |
| SECONDARY Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab |
6107; 6163 | — |
| SECONDARY Part 2: Objective Response Rate (ORR) |
10.5; 11.0 | 0.8757 |
| SECONDARY Part 2: Progression-free Survival (PFS) |
2.9; 2.8 | 0.6906 |
| SECONDARY Part 2: Overall Survival (OS) |
10.1; 10.9 | 0.9766 |
| SECONDARY Part 2: Duration of Response (DOR) |
11.2; 15.1 | 0.8375 |
| SECONDARY Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score |
74.53; 72.15; -6.23; -4.23; -4.55; -4.99 | — |
| SECONDARY Part 2: Change From Baseline in EORTC IL57 Role Functioning Score |
74.93; 74.86; 0.31; -4.36; -3.29; -4.67 | — |
| SECONDARY Part 2: Change From Baseline in EORTC IL57 Global Health Status Score |
66.52; 63.50; -3.54; -2.48; -2.91; -1.83 | — |
| SECONDARY Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) |
77.29; 75.56; 50.67; 61.21 | — |
| SECONDARY 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 |
49.6; 56.7; 36.3; 28.6; 8.0; 10.1 | — |
| SECONDARY Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration |
14.3; 20.6 | — |
| SECONDARY Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration |
5.7 | — |
| SECONDARY Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire |
24.0; 16.0; 26.0; 12.0; 22.0 | — |
| SECONDARY Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire |
74.0; 14.0; 12.0 | — |
| SECONDARY Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire |
32.0; 38.0; 30.0 | — |
| SECONDARY Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire |
78.6; 14.3; 7.1 | — |
| SECONDARY Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire |
54.8; 34.5; 10.7 | — |
| SECONDARY Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire |
34.5; 50.0; 13.1; 2.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT03735121) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.