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A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Phase 2 trial testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody in Non-Small Cell Lung Cancer in 181 participants. Completed in 5 September 2023.
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 181 |
| Start date | 20 April 2017 |
| Primary completion | 7 May 2020 |
| Estimated completion | 5 September 2023 |
| Sites | 19 locations across United States |
Genentech, Inc. — full company profile →
18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 20.3 |
ORR was defined as percentage of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1, assessed in the programmed death ligand 1 (PD-L1) positive (participants with combined tumor cell (TC)/ immune cell (IC) score categorized as TC1/2/3 or IC1/2/3) and PD-L1 negative (participants with TC/IC score was categorized as TC0 and IC0) groups. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 millimeters (mm). PR was defined
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 13.3 | 5.9 – 24.6 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 1.9 | 0.1 – 10.3 |
Major pathologic response (MPR) was defined as ≤10% of viable tumor cells, as scored by a pathologist, based on surgical resection as defined by prior studies. MPR was assessed based on participants tumor cell (TC) and immune cell (IC) score. The participants were considered as PD-L1- positive if their combined TC/IC score was categorized as TC1/2/3 or IC1/2/3 and the participants were considered PD-L1 negative if TC/IC score was categorized as TC0 and IC0. Percentages have been rounded off to the nearest decimal point.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 29.8 | 18.4 – 43.4 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 13.5 | 5.6 – 25.8 |
An adverse event (AE) was defined as any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 177 |
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. Whole-exome sequencing (WES) was run, and the consequences of each mutation were determined using Ensembl Variant Effect Predictor (VEP). Mutation load (i.e. tumor mutation burden (TMB)) was defined as the number of variants altering protein sequence as outlined by VEP divided by 34 Megabase (MB) of assay target region. The final value was reported as number of mutations per megabase (mut/MB). It was divided into three groups: TMB \<10 mut/MB; TMB ≥ 10 mut/MB to \<16 mut/MB; and TMB ≥16 mut/MB.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 16.7 | 8.3 – 28.5 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 9.1 | 0.2 – 41.3 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 33.3 | 11.8 – 61.6 |
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by neoantigen score, which was assessed based on the number of highly immunogenic, expressed neoantigens detected at baseline. Median splits were applied for analyses of MPR. Neoantigen scores \>/= 73 (i.e. \>/= 73 highly immunogenic, expressed neoantigens detected at baseline) were considered as high scores, and scores \<73 (i.e. \<73 highly immunogenic, expressed neoantigens detected at baseline) were considered as low neoantigen scores. Percentages have been rounded off to th
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 19.4 | 7.5 – 37.5 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 25.8 | 11.9 – 44.6 |
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene set variation analysis (GSVA) scores. Bulk ribonucleic acid (RNA) from baseline tumor samples were assessed using GSVA for a T effector cell (Teff) signature comprising the following genes: cluster of differentiation 8A (CD8A), eomesodermin (EOMES), granzyme A (GZMA), T-box transcription factor 21 (TBX21), interferon-gamma (IFNG), granzyme B (GZMB), C-X-C motif chemokine ligand 9 (CXCL9), and C-X-C motif chemokine ligand 10 (CXCL10). Tertile splits were applied to GSVA s
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 17.6 | 3.8 – 43.4 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 35.3 | 14.2 – 61.7 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 33.3 | 13.3 – 59.0 |
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene expression signatures. Bulk RNA from baseline tumor samples were assessed using xCell immune score. Tertile splits were applied to xCell immune scores, categorized as lower, middle, and upper scores, which indicated the relative levels of immune cell gene expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 29.4 | 10.3 – 56.0 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 23.5 | 6.8 – 49.9 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab | 33.3 | 13.3 – 59.0 |
Time frame: Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Atezolizumab |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Pyrexia | General disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | — |
| Empyema | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Cardiac failure acute | Cardiac disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Ileus | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Diverticulitis | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Tooth infection | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Reaction | System | Atezolizumab |
|---|---|---|
| Fatigue | General disorders | — |
| Procedural pain | Injury, poisoning and procedural complications | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Pyrexia | General disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Aspartate aminotransferase increased | Investigations | — |
| Anxiety | Psychiatric disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Chills | General disorders | — |
| Oedema peripheral | General disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hypertension | Vascular disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Weight decreased | Investigations | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension | Vascular disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — |
| Dysgeusia | Nervous system disorders | — |
Most-reported serious reactions: Pneumonia, Pneumonitis, Dyspnoea, Pyrexia, Atrial fibrillation, Pneumothorax, Pulmonary air leakage, Empyema.
Data from ClinicalTrials.gov NCT02927301 adverse events section.
This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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