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Protocol NumberGO40290
NCT Number(ClinicalTrials.gov Identfier)NCT03563716

2018-06-08 - 2021-01-31

Phase II

Terminated6

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    Genentech, Inc

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Terminated

Audit

None

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Audit

CRO

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Terminated

Audit

None

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

Test Drug

MTIG7192A (RO7092284)

Active Ingredient

MTIG7192A (RO7092284)

Dosage Form

IV

Dosage

400 mg/20 ml

Endpoints

Primary Outcome Measures :
Objective Response Rate (ORR) [ Time Frame: From baseline until a total of 80 progression free survival (PFS) events have occurred (up to approximately 11 months) ]
ORR, defined as a complete response (CR) or partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.

Progression Free Survival (PFS) [ Time Frame: From baseline until a total of 80 PFS events have occurred (up to approximately 11 months) ]
PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).


Secondary Outcome Measures :
Duration of Objective Response (DOR) [ Time Frame: Up to 5 years ]
DOR, defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).

Overall Survival (OS) [ Time Frame: Up to 5 years ]
OS, defined as the time from randomization to death from any cause.

Percentage of Participants With Adverse Events [ Time Frame: Up to 5 years ]
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event 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 adverse events.

Serum Concentrations of Tiragolumab [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
Serum Concentrations of Atezolizumab [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]

Inclution Criteria

Inclusion Criteria
Patients must meet all of the following criteria to be eligible for study entry:
 Signed Informed Consent Form
 Age  18 years
 Ability to comply with the study protocol, in the judgment of the investigator
 ECOG Performance Status of 0 or 1 (see Appendix 6)
 Histologically or cytologically documented locally advanced unresectable NSCLC
(i.e., Stage IIIB not eligible for definitive chemoradiotherapy), recurrent, or
metastatic NSCLC (i.e., Stage IV) (per the Union Internationale Contre le
Cancer/American Joint Committee on Cancer [UICC/AJCC] staging system,
Detterbeck et al. 2009) of either squamous or non-squamous histology
– Patients with tumors of mixed histology must be classified as non-squamous or
squamous based on the major histological component.
 No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
- Patients who received prior neo-adjuvant, adjuvant chemotherapy, and/or
chemoradiotherapy with curative intent for non-metastatic disease are eligible
for the study if the therapy was completed at least 6 months prior to initiation of
study treatment.
 Tumor PD-L1 expression with a TPS  1%, as determined by the PD-L1 IHC 22C3
pharmDx assay performed by a local laboratory or by a central laboratory on
previously obtained archival tumor tissue or tissue obtained from a biopsy at
screening
 Confirmed availability of representative tumor specimens in formalin-fixed,
paraffin-embedded (FFPE) blocks (preferred) or at least 1520 unstained serial
slides, along with an associated pathology report. If central testing for EGFR
mutations and/or ALK translocations are required, an additional 5 unstained slides
need to be provided.
– Tumor tissue should be of good quality on the basis of total and viable tumor
content. Acceptable samples include core-needle biopsies for deep tumor
tissue (with a minimum of three cores) or excisional, incisional, punch, or
forceps biopsies for cutaneous, subcutaneous, or mucosal lesions.
– Fine-needle aspirations, brushings, cell pellets from pleural effusions, and
lavage samples are not acceptable.
– Tumor tissues from bone metastases are not evaluable for tumor PD-L1
expression by IHC and are therefore not acceptable.
– For patients whose initial archival tumor tissue sample has PD-L1 expression
with a TPS  1% as determined by the PD-L1 IHC 22C3 pharmDx assay, a
biopsy can be performed at screening to submit fresh tissue for the purposes of
testing PD-L1 status. A PD-L1 IHC 22C3 pharmDx test result with a TPS  1%
in any tumor tissue sample will satisfy the eligibility requirement.
– If archival tissue is either insufficient or unavailable, the patient may consent to
an optional biopsy at screening if the biopsy site is safely accessible. If a
biopsy cannot be provided, the patient may still be eligible upon discussion with
the Medical Monitor if the patient can provide  10 unstained, serial slides.
 Measurable disease, as defined by RECIST v1.1
– Previously irradiated lesions can only be considered measurable disease if
disease progression has been unequivocally documented at that site since
radiation and the previously irradiated lesion is not the only site of measurable
disease.
 Life expectancy  12 weeks
 Adequate hematologic and end-organ function, defined by the following laboratory
results, obtained within 14 days prior to the first study treatment (Cycle 1, Day 1
[C1D1]):
– ANC  1500 cells/L (without granulocyte colony-stimulating factor support
within 14 days prior to C1D1)
– WBC count  2500/L
– Lymphocyte count  500/L
– Platelet count  100,000/L (without transfusion within 14 days prior to C1D1)
– Hemoglobin  9.0 g/dL
Patients may be transfused or receive erythropoietic treatment as per local
standard of care.
– Total bilirubin  1.5 upper limit of normal (ULN)
Patients with known Gilbert’s disease who have serum bilirubin level
3ULN may be enrolled.
– AST and ALT  3 ULN, with the following exception:
Patients with documented liver metastases: AST and ALT  5 ULN
– ALP  2.5 ULN, with the following exception:
Patients with documented liver or bone metastases: ALP  5 ULN
– Serum albumin  2.5 g/dL
– LDH  3 ULN
– aPTT and PT and/or INR  1.5 ULN
This applies only to patients who are not receiving therapeutic
anticoagulation.
Patients receiving therapeutic anticoagulation should be on a stable dose
for at least 1 week prior to C1D1.
– Measured or calculated creatinine clearance 50 mL/min on the basis of the
Cockcroft-Gault glomerular filtration rate estimation:
 For women of childbearing potential (including women who have had a tubal
ligation): Serum pregnancy test must be performed and documented as negative
within 14 days prior to C1D1
 For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods, and agreement to refrain
from donating eggs, as defined below:
– Women must remain abstinent or use contraceptive methods with a failure rate
of  1% per year during the treatment period and for at least 5 months after the
last dose of study drugs. Women must refrain from donating eggs during this
same period.
– A woman is considered to be of childbearing potential if she is postmenarcheal,
has not reached a postmenopausal state (12 continuous months of
amenorrhea with no identified cause other than menopause), and has not
undergone surgical sterilization (removal of ovaries and/or uterus).
– Examples of contraceptive methods with a failure rate of  1% per year include
bilateral tubal ligation, male sterilization, established proper use of hormonal
contraceptives that inhibit ovulation, hormone-releasing intrauterine devices,
and copper intrauterine devices.
– Hormonal contraceptive methods must be supplemented by a barrier method
plus spermicide.
– The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical study and the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation
methods) and withdrawal are not acceptable methods of contraception.
 For men: agreement to remain abstinent (refrain from heterosexual intercourse) or
use contraceptive measures, and agreement to refrain from donating sperm, as
specified below:
– With female partners of childbearing potential or pregnant female partners, men
must remain abstinent or use a condom during the treatment period and for at
least 90 days after the last dose of study treatment to avoid exposing the
embryo. Men must refrain from donating sperm during this same period.
– The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical study and the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation
methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria

Exclusion Criteria
Patients who meet any of the criteria in the following sections will be excluded from
study entry.

Cancer-Specific Exclusions
Patients who meet any of the following cancer-specific criteria will be excluded from
study entry:
 Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an
ALK fusion oncogene are excluded from the study as follows:
– Patients with non-squamous NSCLC who have an unknown EGFR or ALK
status will be required to be tested at pre-screening/screening.
– Patients with squamous NSCLC who have an unknown EGFR or ALK status
will not be required to be tested at pre-screening/screening.
– EGFR and/or ALK status may be assessed locally or at a central laboratory
only if local testing is not available.
 Symptomatic, untreated, or actively progressing CNS metastases
– Patients with a history of treated asymptomatic CNS metastases are eligible,
provided they meet all of the following criteria:
Measurable disease, per RECIST v1.1, must be present outside the CNS.
No history of intracranial hemorrhage or spinal cord hemorrhage.
Only supratentorial and cerebellar metastases will be allowed (i.e., no
metastases to midbrain, pons, medulla, or spinal cord). No stereotactic
radiation within 7 days or whole-brain radiation within 14 days prior to C1D1.
No ongoing requirement for corticosteroids as therapy for CNS disease;
anticonvulsant therapy at a stable dose is allowed.
No evidence of interim progression between the completion of CNS-directed
therapy and the screening radiographic study.
Note: Patients with new asymptomatic CNS metastases detected at
screening are eligible for the study after receiving radiotherapy and/or
surgery. Following treatment, these patients may be eligible without the
need to repeat the additional brain scan prior to randomization, if all other
criteria are met.
 Spinal cord compression not definitively treated with surgery and/or radiation, and/or
previously diagnosed and treated spinal cord compression without evidence that
disease has been clinically stable for 2 weeks prior to screening
 History of leptomeningeal disease
 Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (i.e., once monthly or more frequently)
– Patients with indwelling catheters (e.g., PleurX
) are allowed.
 Uncontrolled tumor-related pain
– Patients requiring pain medication must be on a stable regimen at study entry.
– Symptomatic lesions amenable to palliative radiotherapy (e.g., bone
metastases or metastases causing nerve impingement) should be treated prior
to enrollment. Patients should be recovered from the effects of radiation.
– Asymptomatic metastatic lesions whose further growth would likely cause
functional deficits or intractable pain (e.g., epidural metastasis that is not
presently associated with spinal cord compression) should be considered for
loco-regional therapy if appropriate prior to enrollment.
 Uncontrolled hypercalcemia (ionized calcium  1.5 mmol/L or calcium  12 mg/dL or
corrected serum calcium  ULN) or symptomatic hypercalcemia requiring continued
use of bisphosphonate therapy or denosumab
– Patients who are receiving bisphosphonate therapy or denosumab specifically
to prevent skeletal events and who do not have a history of clinically significant
hypercalcemia are eligible.
– Patients who are receiving denosumab prior to randomization must be willing
and eligible to discontinue its use and replace it with a bisphosphonate instead
while on study.
 Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death and/or treated with
expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal
carcinoma in situ, or Stage I uterine cancer)

General Medical Exclusions
Patients who meet any of the following general medical criteria will be excluded from
study entry:
 Inability to comply with study and/or follow-up procedures
 Pregnant, lactating, or breastfeeding women
 Evidence of significant uncontrolled concomitant disease that could affect
compliance with the protocol or interpretation of results (e.g., uncontrolled major
seizure disorder or superior vena cava syndrome)
 Known clinically significant liver disease, including active viral, alcoholic, or other
hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
Significant cardiovascular disease, such as New York Heart Association cardiac
disease (Class II or greater), myocardial infarction or cerebrovascular accident
within 3 months prior to randomization, unstable arrhythmias, or unstable angina
 Severe infections within 4 weeks prior to initiation of study treatment, including but
not limited to hospitalization for complications of infection, bacteremia, or severe
pneumonia
 Received oral or IV antibiotics (including antifungals) within 2 weeks prior to
randomization
– Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract
infection or chronic obstructive pulmonary disease exacerbations) are eligible.
 Major surgical procedure within 4 weeks prior to randomization, or anticipation of
need for a major surgical procedure during the course of the study
 Inability to understand the local language(s) for which the EORTC QLQ-C30 is
available
 Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug, that may affect the interpretation
of the results, or that may render the patient at high risk from treatment
complications

Treatment-Specific Exclusions
Patients who meet any of the following treatment-specific criteria will be excluded from
study entry:
 History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
 Known hypersensitivity or allergy to CHO cell products or any component of the
atezolizumab formulation
 Active or history of autoimmune disease with the following exceptions:
– Patients with a history of autoimmune-related hypothyroidism on a stable dose
of thyroid replacement hormone may be eligible for this study following
discussion with the Medical Monitor.
– Patients with controlled type 1 diabetes mellitus on a stable insulin regimen
may be eligible for this study following discussion with the Medical Monitor.
– Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis would be
excluded) are permitted provided they meet the following conditions:
Rash must cover less than 10% of body surface area (BSA).
Disease is well controlled at baseline and only requires low potency topical
steroids.
No acute exacerbations of the underlying condition within the last
12 months requiring treatment with either PUVA (psoralen plus ultraviolet A
radiation), methotrexate, retinoids, biologic agents, oral calcineurin
inhibitors, and/or high potency or oral steroids.
 Prior allogeneic bone marrow transplantation or prior solid organ transplantation
 History of idiopathic pulmonary fibrosis (including pneumonitis), organizing
pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia),
drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest computed tomography (CT) scan
– History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
 Positive test for HIV at screening
– All patients must be tested for HIV, and patients who test positive for HIV will be
excluded.
 Patients with active HBV infection, defined as having a positive hepatitis B surface
antigen (HBsAg) test at screening
– Patients with past HBV infection or resolved HBV infection (defined as having a
negative HBsAg test and a positive antibody to hepatitis B core antigen
[anti-HBc] antibody test) are eligible.
– HBV DNA must be obtained in these patients prior to C1D1, and must
demonstrate no active infection.
 Patients with active HCV infection, defined as having a positive HCV antibody test
followed by a positive HCV RNA test at screening
– Patients positive for HCV antibody are eligible only if the PCR is negative for
HCV RNA.
 Active tuberculosis
 Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment or anticipation that such a live attenuated vaccine will be required during
the study
– Influenza vaccination should be given during influenza season only. Patients
must not receive live, attenuated influenza vaccine (e.g., FluMist
) within
4 weeks prior to enrollment or at any time during the study, and for 5 months
following the last study treatment.
 Treatment with systemic corticosteroids or other systemic immunosuppressive
medications (including but not limited to prednisone  10 mg/day, cyclophosphamide,
azathioprine, methotrexate, thalidomide, and tumor necrosis factor [TNF-]
antagonists) within 2 weeks prior to randomization
– Patients who have received acute, low-dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea) may be
eligible for this study following discussion with the Medical Monitor.
– The use of inhaled corticosteroids is allowed.
– The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic
hypotension is allowed.
– Physiologic doses of corticosteroids for adrenal insufficiency may be allowed
after discussion with the Medical Monitor

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    120 participants

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