Trial record 1 of 1 for:
BP40657
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT03735121 |
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Recruitment Status :
Active, not recruiting
First Posted : November 8, 2018
Last Update Posted : June 10, 2022
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: Atezolizumab Drug: rHuPH20 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 437 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Intervention study model can be sequential or in parallel. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
| Actual Study Start Date : | December 27, 2018 |
| Actual Primary Completion Date : | April 21, 2022 |
| Estimated Study Completion Date : | May 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atezolizumab (Part 2)
Atezolizumab
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Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq |
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Experimental: Cohort 1: Atezolizumab+rHuPH20 (Part 1)
Atezolizumab+rHuPH20, followed by Atezolizumab
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Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq Drug: rHuPH20 rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE |
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Experimental: Cohort 2: Atezolizumab+rHuPH20 (Part 1)
Atezolizumab+rHuPH20, followed by Atezolizumab
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Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq Drug: rHuPH20 rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE |
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Experimental: Cohort 3: Atezolizumab+rHuPH20(Part 1)
Atezolizumab+rHuPH20, followed by Atezolizumab
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Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq Drug: rHuPH20 rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE |
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Experimental: Atezolizumab + rHuPH20 (Part 2)
Atezolizumab + rHuPH20
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Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq Drug: rHuPH20 rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE |
Primary Outcome Measures :
- Observed Concentration of Atezolizumab in Serum at Cycle 1 in Part 1 [ Time Frame: Predose of Cycle 2. Cycle length is 14 days or 21 days. ]
- Observed Concentration of Atezolizumab in Serum at Cycle 1 in Part 2 [ Time Frame: Predose of Cycle 2. Cycle length is 21 days. ]
- Area Under the Concentration-Time Curve from Time Zero to 21 Days (AUC₀-₂₁) of Atezolizumab in Part 2 [ Time Frame: At Cycle 1. Cycle length is 21 days. ]
Secondary Outcome Measures :
- Concentration at the End of a Dosing Interval (Ctrough) of Atezolizumab in Part 1 [ Time Frame: At pre-defined intervals from first administration of study drug up to treatment discontinuation visit (up to approximately 5.3 years). ]
- Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Part 1 [ Time Frame: At pre-defined intervals from first administration of study drug up to treatment discontinuation visit (up to approximately 5.3 years). ]
- Time to Maximum Plasma Concentration (Tmax) of Atezolizumab in Part 1 [ Time Frame: At pre-defined intervals from first administration of study drug up to treatment discontinuation visit (up to approximately 5.3 years). ]
- Serum Atezolizumab Concentration During SC Administration in Part 1 [ Time Frame: At pre-defined intervals from first administration of study drug up to treatment discontinuation visit (up to approximately 5.3 years). ]
- Percentage of Participants with Adverse Events in Part 1 and Part 2 [ Time Frame: Up to end of the study (approximately 5.3 years) ]
- Model-Predicted Ctrough at Cycle 1 (Ctrough Cycle 1) of Atezolizumab in Part 2 [ Time Frame: Predose of Cycle 2. Cycle length is 21 days. ]
- Model-Predicted Ctrough at Steady Stage (Ctrough,ss) of Atezolizumab in Part 2 [ Time Frame: At pre-defined intervals from first administration of study drug up to treatment discontinuation visit (up to approximately 5.3 years). ]
- Model-Predicted AUC at Steady Stage (AUCss) of Atezolizumab in Part 2 [ Time Frame: At pre-defined intervals from first administration of study drug up to treatment discontinuation visit (approximately 5.3 years). ]
- Overall Patient-Reported Adverse Event Burden Over Time in Part 2 [ Time Frame: Up to treatment discontinuation visit (up to approximately 5.3 years) ]
- Objective Response Rate (ORR) in Part 2 [ Time Frame: Up to treatment discontinuation visit (up to approximately 5.3 years) ]ORR is defined as the proportion of patients with a partial response (PR) or complete response (CR) as determined by the investigator according to RECIST v1.1.
- Progression-Free Survival (PFS) in Part 2 [ Time Frame: Up to treatment discontinuation visit (up to approximately 5.3 years) ]PFS is defined as the time from the date of study entry to the date of documented disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever is earlier.
- Overall Survival (OS) in Part 2 [ Time Frame: Up to 5.3 years ]
- Duration of Response (DOR) in Part 2 [ Time Frame: Up to treatment discontinuation visit (up to approximately 5.3 years) ]Duration of response (DOR), defined as the time from first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
- Functioning and Global Health Status Over Time in Part 2 [ Time Frame: Up to treatment discontinuation visit (up to approximately 5.3 years) ]
- Overall Satisfaction With Treatment in Part 2 [ Time Frame: Up to treatment discontinuation visit (up to approximately 5.3 years) ]Overall satisfaction with treatment, as assessed by the modified satisfaction with therapy (SWT) scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ).
- Percentage of Participants With ADAs to Atezolizumab in Part 2 [ Time Frame: Baseline to pre-defined intervals up treatment discontinuation (approximately 5.3 years) ]Percentage of participants with ADAs to atezolizumab after SC administration or IV administration relative to the prevalence of ADAs at baseline.
- Percentage of Participants Wtih ADAs to rHuPH20 in Part 2 [ Time Frame: Baseline to pre-defined intervals up to treatment discontinuation (approximately 5.3 years) ]Percentage of participants with ADAs to rHuPH20 after SC administration relative to the prevalence of ADAs at baseline.
- Convenience, Potential Time Savings, and Overall Satisfaction With Atezolizumab SC Compared With Atezolizumab IV in Part 2 [ Time Frame: Up to 5.3 years ]Convenience, potential time savings, and overall satisfaction with atezolizumab SC compared with atezolizumab IV, as assessed by the HCP SC versus IV Perspective Questionnaire.
- Convenience, Ease of Administration, and Overall Satisfaction With Atezolizumab SC in Part 2 [ Time Frame: Up to 5.3 years ]Convenience, ease of administration, and overall satisfaction with atezolizumab SC, as assessed by the HCP Subcutaneous Perspective Questionnaire.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- 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 EGFR status
Exclusion Criteria:
- Symptomatic, untreated, or actively progressing 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 PD-L1 expression status with an intention to treat the patient if positive
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735121
Locations
Show 94 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT03735121 |
| Other Study ID Numbers: |
BP40657 |
| First Posted: | November 8, 2018 Key Record Dates |
| Last Update Posted: | June 10, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Atezolizumab Antineoplastic Agents |